Leaflet: information for the user

Olmesartán/Amlodipino/Hidroclorotiazida Krka 20 mg/5 mg/12,5 mg film-coated tablets

Olmesartán/Amlodipino/Hidroclorotiazida Krka 40 mg/5 mg/12,5 mg film-coated tablets

Olmesartán/Amlodipino/Hidroclorotiazida Krka 40 mg/5 mg/25 mg film-coated tablets

Olmesartán/Amlodipino/Hidroclorotiazida Krka 40 mg/10 mg/12,5 mg film-coated tablets

Olmesartán/Amlodipino/Hidroclorotiazida Krka 40 mg/10 mg/25 mg film-coated tablets

olmesartán medoxomilo/amlodipino/hidroclorotiazida

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medicine contains three active substances called olmesartan medoxomilo, amlodipine (as amlodipine besylate) and hydrochlorothiazide. The three substances help control high blood pressure.

• Olmesartan medoxomilo belongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called “calcium channel blockers”. Amlodipine also decreases blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics.(“medicines that increase the elimination of urine”)Decreases blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

The action of these substances contributes to decreasing blood pressure. Olmesartan/hydrochlorothiazide/amlodipine is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartan medoxomilo and amlodipine, taken as a fixed combination, or
• in patients who are already taking a fixed combination of olmesartan medoxomilo and hydrochlorothiazide, together with tablets containing only amlodipine, or a fixed combination of olmesartan medoxomilo and amlodipine, together with tablets containing only hydrochlorothiazide.

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Krka if:

• You are allergic to olmesartan medoxomil, amlodipine, or a group of calcium channel blockers (dihidropiridinas), hidroclorotiazida, or substances similar to hidroclorotiazida (sulfonamidas), or any of the other components of this medication (listed in section 6). If you think you may be allergic, inform your doctor before taking this medication.
• You have severe kidney problems.
• You have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.
• You have low levels of potassium or sodium in your blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in your blood, that do not improve with treatment.
• You are more than 3 months pregnant. (It is also best to avoid this medication at the beginning of pregnancy - see section “Pregnancy and breastfeeding”).
• You have severe liver problems, bile secretion problems, or obstruction of bile duct drainage from the gallbladder (e.g., by gallstones), or have jaundice (yellow skin and eyes).
• You have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate, or shock (including cardiogenic shock, which means shock due to severe cardiac problems).
• You have very low blood pressure.
• Your heart's blood flow is slow or blocked. This can occur if the blood vessels or heart valves that capture blood from the heart become narrowed (aortic stenosis).
• You have low cardiac output after a heart attack (acute myocardial infarction). Low cardiac output can make you feel short of breath or have swelling in your feet and ankles.

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Krka if any of these cases occur.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán/Amlodipino/Hidroclorotiazida Krka.

Tell your doctorif you are taking any of the following medications used to treat high blood pressure:

• An ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskirén.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood at regular intervals.

See also the information under the heading “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Krka if:”.

Tell your doctorif you have any of the following health problems:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Intense vomiting, diarrhea, treatment with high doses of “diuretics” (medications that increase urine production), or if you are on a low-sodium diet.
• High levels of potassium in your blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after being in the sun or in a tanning bed.
• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hidroclorotiazida, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking this medication.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking this medication, seek medical attention immediately.

Contact your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• Decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased eye pressure, which can occur within hours or weeks of taking this medication. This can lead to permanent visual impairment if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing it.

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with alterations in blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

This medication may cause an increase in lipid and uric acid levels in your blood. Your doctor will likely want to perform blood tests from time to time to monitor these possible changes.

You may experience changes in the levels of certain chemicals in your blood called electrolytes. Your doctor will likely want to perform blood tests from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate. Tell your doctor if you notice any of these symptoms.

If you are undergoing parathyroid function tests, stop taking this medication before the tests are performed.

It is reported to athletes that this medication contains a component that can result in a positive analytical result for doping control.

Inform your doctor if you are pregnant (or think you may be). This medication is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it can cause severe damage to your baby if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

This medication is not recommended for use in children and adolescents under 18 years.

Other medications and Olmesartán/Amlodipino/Hidroclorotiazida Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

• Other blood pressure-lowering medications, as they may increase the effect of this medication. Your doctor may need to change your dose and/or take other precautions: If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Krka if” and “Warnings and precautions”).
• Lithium(a medication used to treat mood changes and certain types of depression) if used at the same time as this medication may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Diltiazem,verapamilo,used for heart rhythm and high blood pressure problems.
• Rifampicin,erythromycin, clarithromycin, tetracyclines, or ciprofloxacin,antibioticsused for tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), a herbal remedy for depression treatment.
• Cisaprida, used to increase stomach and intestinal movement.
• Difemanilo, used to treat slow heart rhythm or to reduce sweating.
• Halofantrina, used for malaria.
• Vincamina IV, used to improve blood flow to the nervous system.
• Amantadina,used for Parkinson's disease.
• Electrolyte supplements, sodium substitutes that contain potassium, “diuretics”(medications that increase urine production),heparin(to thin the blood and prevent blood clots), ACE inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolona (a medication for treating mouth and stomach ulcers), penicillin G sodium (an antibiotic also called benzylpenicillin sodium), some pain relievers such as aspirin or salicylates. The use of these medications at the same time as Olmesartán/Amlodipino/Hidroclorotiazida may alter potassium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs)(medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as this medication may increase the risk of kidney problems. The effect of this medication may be reduced by NSAIDs. If high doses of salicylates are used, it may increase the toxic effect on the central nervous system.
• Sedatives, sleep-inducing medications, and antidepressants, used with this medication may cause a sudden drop in blood pressure when standing up.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of this medication. Your doctor may advise you to take Olmesartán/Amlodipino/Hidroclorotiazida at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of this medication.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medications, such as atropine and biperiden.
• Calcium supplements.
• Dantroleno(in perfusion for severe body temperature anomalies).
• Simvastatina, used to lower cholesterol and triglyceride levels in the blood.
• Medications used to control the body's immune response(e.g., tacrolimus, sirolimus, temsirolimus, everolimus, and ciclosporina), which allows your body to accept the transplanted organ.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications for:

• Treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Treating low blood sugar(e.g., diazoxide) orhigh blood pressure(e.g., beta-blockers, methyldopa), as Olmesartán/Amlodipino/Hidroclorotiazida may affect the mechanism of action of these medications.
• Treating heart rhythm problems,such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections.
• Treating HIV/AIDS(e.g., ritonavir, indinavir, nelfinavir).
• Treating fungal infections(e.g., ketoconazole, itraconazole, amphotericin).
• Treating heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digital.
• Treating cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increasing blood pressureanddecreasing heart rate,such as noradrenaline.
• Treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lowering cholesterol levels in the blood,such as cholestyramine and colestipol.
• Lowering blood sugar levels,such as metformin or insulin.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking Olmesartán/Amlodipino/Hidroclorotiazida Krka with food and drinks

Olmesartán/Amlodipino/Hidroclorotiazida Krka can be taken with or without food.

People taking this medication should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the levels of the active ingredient amlodipine in the blood, which may cause an unpredictable increase in the effect of this medication to lower blood pressure.

Be careful when drinking alcohol while taking this medication, as some people may feel dizzy, nauseous, or experience headaches. If this happens, do not drink any alcohol.

Older patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure whenever your dose is increased, to ensure that your blood pressure does not drop too low.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or think you may be). Your doctor will advise you to stop taking this medication before becoming pregnant or as soon as you know you are pregnant, and will recommend another medication in place of Olmesartán/Amlodipino/Hidroclorotiazida Krka. This medication is not recommended for use during pregnancy, and it should not be taken if you are more than 3 months pregnant, as it can cause severe damage to your baby if taken during this period.

If you become pregnant while taking this medication, inform and visit your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. It has been shown that amlodipine and hidroclorotiazida pass into breast milk in small amounts. This medication is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

You may feel drowsy, nauseous, or experience headaches while taking this medication for high blood pressure. If this happens, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Olmesartán/Amlodipino/Hidroclorotiazida Krka contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose of this medication is one tablet per day.
• The tablets can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). Do not chew the tablet. Do not take the tablets with grapefruit juice.
• If possible, take your daily dose at the same time every day, for example at breakfast time.

If you take more Olmesartán/Amlodipino/Hidroclorotiazida Krka than you should

If you take more tablets than you should, you will probably experience a drop in blood pressure, accompanied by symptoms such as dizziness, and a fast or slow heart rate.

You may accumulate excess fluid in the lungs (pulmonary edema) causing difficulty breathing that may develop up to 24-48 hours after ingestion.

If you take more tablets than you should or if a child accidentally ingests some tablets, contact your doctor immediately or go to the nearest emergency center and bring with you the packaging of the medication or this leaflet. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Olmesartán/Amlodipino/Hidroclorotiazida Krka

If you forgot to take a dose, take the usual dose the next day. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Olmesartán/Amlodipino/Hidroclorotiazida Krka

It is essential to continue taking this medication, unless your doctor tells you to stop treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

The following side effects may be serious, although they affect only a small group of people:

During treatment with Olmesartán/Amlodipino/Hidroclorotiazida, allergic reactions with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash may occur.If this happens, stop taking this medicine and consult your doctor immediately.

Olmesartán/Amlodipino/Hidroclorotiazida may cause a pronounced drop in blood pressure in susceptible patients.If this happens, stop taking this medicine, consult your doctor immediately, and remain lying down in a horizontal position.

Unknown frequency: If you experience yellowing of the white of the eyes, dark urine, skin itching, even if you started treatment with Olmesartán/Amlodipino/Hidroclorotiazida some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

This medicine is a combination of three active substances. The following information, first, describes the side effects reported so far with the olmesartán/amlodipino/hidroclorotiazida combination (in addition to those already mentioned) and, second, the known side effects of each of the active substances separately, or when two of the substances are taken together.

To give you an idea of the number of patients who may experience side effects, these have been classified as frequent, infrequent, rare, and very rare.

These are other side effects known so far with olmesartán/amlodipino/hidroclorotiazida:

If these side effects occur, they are often mild andit is not necessary to interrupt treatment.

Frequent

(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat, and nose, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, sensation of urgency to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test results.

Infrequent

(may affect up to 1 in 100 people)

Dizziness when getting up, vertigo, rapid heartbeat, sensation of fainting, flushing and sensation of heat in the face, cough, dry mouth, muscle weakness, inability to have or maintain an erection.

These are the side effects known for each of the active substances separately or when two of the substances are taken together:

They may be side effects due to Olmesartán/Amlodipino/Hidroclorotiazida Krka, even if they have not been observed so far with this medicine.

Very frequent

(may affect more than 1 in 10 people)

Edema (fluid retention).

Frequent

(may affect up to 1 in 10 people)

Bronchitis, stomach and intestine infection, vomiting, increased blood sugar, sugar in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal secretion or congestion, sore throat, difficulty breathing, cough, abdominal pain, stomach burning, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Infrequent

(may affect up to 1 in 100 people)

Reduction in the number of a type of blood cell called platelets, which can cause easy bruising or prolong bleeding time, anaphylactic reactions, abnormal decrease in appetite (anorexia), sleep problems, irritability, mood changes including anxiety, sensation of depression, chills, sleep disorders, alteration of taste, loss of consciousness, decrease in sense of touch, sensation of numbness, worsening of myopia, ringing in the ears (tinnitus), angina (chest pain or discomfort known as angina pectoris),irregular heartbeats, rash, hair loss, allergic skin inflammation, skin redness, purple patches or spots on the skin due to small hemorrhages (purpura), skin discoloration, red itchy patches (urticaria), increased sweating, pruritus, skin rash, skin reactions to light, such as sunburn or skin eruption, muscle pain, urination problems, sensation of needing to urinate at night, breast enlargement in men, decreased libido, swelling of the face, sensation of discomfort, weight gain or loss, fatigue.

Rare

(may affect up to 1 in 1,000 people)

Salivary gland inflammation and pain, decrease in the number of white blood cells in the blood, which could increase the risk of infections, decrease in the number of red blood cells (anemia), bone marrow damage, restlessness, sensation of loss of interest (apathy), seizures (convulsions), yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of small blood vessels and skin blood vessels, pancreatitis, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pain and cold hands and fingers, severe skin reactions including intense skin eruption, urticaria, skin redness, severe itching, blisters, skin peeling, and inflammation, Stevens-Johnson syndrome, toxic epidermal necrolysis, sometimes very severe, movement impairment, acute kidney failure, non-infectious kidney inflammation, kidney function decrease, fever.

Very rare

(may affect up to 1 in 10,000 people)

High muscle tension, numbness of hands or feet, heart attack, stomach inflammation, gum thickening, intestinal obstruction, liver inflammation, acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency

(frequency cannot be estimated from available data)

Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma). Tremors, rigid posture, mask-like face, slow movements, and unsteady gait dragging the feet.

Skin and lip cancer (non-melanoma skin cancer).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medicationdoes not require special storage conditions.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Olmesartán/Amlodipino/Hidroclorotiazida Krka

• The active ingredients are olmesartan medoxomilo, amlodipino, and hidroclorotiazida.

20 mg/5 mg/12,5mg:

Each film-coated tablet contains 20 mg of olmesartan medoxomilo, 5 mg of amlodipino (as amlodipino besilato), and 12.5 mg of hidroclorotiazida.

40 mg/5 mg/12,5mg:

Each film-coated tablet contains 40 mg of olmesartan medoxomilo, 5 mg of amlodipino (as amlodipino besilato), and 12.5 mg of hidroclorotiazida.

40 mg/5 mg/25mg:

Each film-coated tablet contains 40 mg of olmesartan medoxomilo, 5 mg of amlodipino (as amlodipino besilato), and 25 mg of hidroclorotiazida.

40 mg/10 mg/12,5mg:

Each film-coated tablet contains 40 mg of olmesartan medoxomilo, 10 mg of amlodipino (as amlodipino besilato), and 12.5 mg of hidroclorotiazida.

40 mg/10 mg/25mg:

Each film-coated tablet contains 40 mg of olmesartan medoxomilo, 10 mg of amlodipino (as amlodipino besilato), and 25 mg of hidroclorotiazida.

• The other components (excipients) are: maize pregelatinized starch, microcrystalline cellulose silicified, (microcrystalline cellulose and anhydrous colloidal silica), lactose monohydrate, croscarmellose sodium, copovidone, and magnesium stearate in the core of the tablet and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, red iron oxide (E172) - only for 40 mg/5 mg/25 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mg, yellow iron oxide (E172) - only for 40 mg/5 mg/12.5 mg, 40 mg/5 mg/25 mg, and black iron oxide (E172) - only for 40 mg/10 mg/25 mg in the coating. See section 2 “Olmesartán/Amlodipino/Hidroclorotiazida Krka contains lactose and sodium”

Appearance of the product and contents of the package

20 mg/5 mg/12,5 mg:

The film-coated tablets (tablets) are white or almost white, round, biconvex, with beveled edges.

Dimensions: diameter 8.5 mm ± 0.5 mm.

40 mg/5 mg/12,5 mg:

The film-coated tablets (tablets) are pale yellowish-brown to yellowish-brown, biconvex, capsule-shaped, engraved with the mark “C1” on one face of the tablet.

Dimensions: 15 mm ± 1 mm x 8 mm ± 1 mm.

40 mg/5 mg/25 mg:

The film-coated tablets (tablets) are pale pinkish-orange, biconvex, capsule-shaped, engraved with the mark “C2” on one face of the tablet.

Dimensions: 15 mm ± 1 mm x 8 mm ± 1 mm.

40 mg/10 mg/12,5 mg:

The film-coated tablets (tablets) are pale pink, biconvex, capsule-shaped, engraved with the mark “C3” on one face of the tablet.

Dimensions: 15 mm ± 1 mm x 8 mm ± 1 mm.

40 mg/10 mg/25 mg:

The film-coated tablets (tablets) are pale greyish-violet to greyish-violet, biconvex, capsule-shaped, scored on both faces of the tablet. The tablet can be divided into equal doses.

Dimensions: 15 mm ± 1 mm x 8 mm ± 1 mm.

Olmesartán/Amlodipino/Hidroclorotiazida Krka is available in packs containing:

• 14, 28, 30, 56, 60, 84, 90, and 98 film-coated tablets in blisters.
• 14, 28, 56, and 98 film-coated tablets in calendarised blisters.

Only some package sizes may be marketed.

Marketing authorisation holder

KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer responsible

KRKA, d.d., Novo mesto, Smarjeska Cesta 6, 8501 Novo Mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, Groden Cuxhaven 27472, Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorised in the member states of the European Economic Area with the following names:

Last revision date of this leaflet:November 2022

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://aemps.gob.es/