Leaflet:Information for the patient

Dolostop Plus 500 mg/150mg film-coated tablets

paracetamol/ibuprofen

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• Do nottake this medicine for more than 3days.
• You should consult a doctor if it worsens or does not improve after 3 days.

This medication contains paracetamol and ibuprofen.

Paracetamol prevents pain signals from reaching the brain.

Ibuprofen belongs to a group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It relieves pain and reduces inflammation (swelling, redness, or pain).

Dolostop Plus is used for the symptomatic treatment of occasional mild to moderate pain.

If you have any doubts, consult your doctor or pharmacist.

You should consult a doctor if it worsens or does not improve after 3 days.

Do not take Dolostop Plus:

• if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• if you have a history of bleeding or perforation of the digestive tract, associated with previous treatment with NSAIDs.
• if you have active or recurrent peptic ulcer (i.e., stomach or duodenal ulcer) or bleeding (two or more distinct episodes of ulceration or hemorrhage diagnosed).
• if you regularly consume large amounts of alcohol.
• if you have severe heart failure, liver failure, or kidney failure.
• if you have active cerebral hemorrhage or other active hemorrhage.
• if you have blood clotting disorders.
• if you have asthma, urticaria, or allergic reactions after taking acetylsalicylic acid or other NSAIDs.
• in the last three months of pregnancy.
• if you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before taking this medication.

Anti-inflammatory and analgesic medications, such as ibuprofen, may be associated with a small increase in the risk of suffering a heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or treatment duration.

Signs of allergic reaction to ibuprofen have been reported, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain. Stop using Dolostop Plus immediately and contact your doctor or emergency medical services if you observe any of these signs.

You should consult your doctor or pharmacist before taking this medication if:

• you have heart problems, such as heart failure or angina pectoris (chest pain), if you have had a heart attack, revascularization surgery, peripheral artery disease (poor circulation in legs or feet due to narrowing or blockage of arteries) or any type of stroke (including "mini-strokes" or transient ischemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, family history of cardiovascular disease or stroke, or if you are a smoker.
• you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Inform your doctor or pharmacist if:

• you have liver disease, hepatitis, kidney disease, or difficulty urinating.
• you consume drugs.
• you are pregnant or trying to become pregnant.
• you are breastfeeding or plan to be.
• you currently have an infection; see the "Infections" heading below.
• you are planning to undergo surgery.
• you have or have had other medical conditions such as:

• acid reflux, indigestion, stomach ulcer, or any other stomach problem.
• bloody vomiting or rectal bleeding.
• intense skin reactions such as exfoliative dermatitis, toxic epidermal necrolysis, and Stevens-Johnson syndrome.
• asthma.
• vision problems.
• tendency to bleed or other blood disorders.
• intestinal problems such as ulcerative colitis or Crohn's disease.
• swelling of the ankles or feet.
• diarrhea.
• genetic disorder or acquired enzyme disorder manifesting with neurological complications or skin problems, or occasionally both, i.e., porphyria.
• smallpox.
• autoimmune disease such as lupus erythematosus or other connective tissue disorders.

Skin reactions

Be especially careful with Dolostop Plus:

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue Dolostop Plus treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medication may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to varicella. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

To avoid the risk of overdose:

• check that other medications do not contain paracetamol,
• respect the maximum recommended doses (see section 3).

Do not consume alcoholic beverages during the use of this medication. The combination of alcohol with this medicationmay cause liver damage.

This product belongs to a group of medications (NSAIDs) that may alter fertility in women. This effect is reversible if the medication is discontinued.

Prolonged use of analgesics may cause headaches, which should not be treated by increasing the medication dose.

The use of this medication may interfere with the results of urine analysis for the detection of 5-hydroxyindoleacetic acid (5HIAA) and cause false-positive results. To avoid false positives, do not take this medication or other products containing paracetamol for several hours before or during the collection of the urine sample.

Children and adolescents

This medication is contraindicated in children and adolescents (under 18 years old).

Other medications and Dolostop Plus

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

This medication may affect other medications or be affected by them. For example:

• anticoagulant medications (i.e., agents that dilute the blood and prevent its coagulation, such as aspirin/acetysalicylic acid, warfarin, and ticlopidine).
• medications that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• medications for treating epilepsy or seizures.
• chloramphenicol, an antibiotic used to treat ear and eye infections.
• probencid, a medication used to treat gout.
• zidovudine, a medication used to treat HIV (the virus causing acquired immunodeficiency syndrome).
• medications used to treat tuberculosis, such as isoniazid.
• salicylates or other NSAIDs.
• diuretics.
• lithium, a medication used to treat some types of depression.
• methotrexate, a medication used to treat arthritis and some types of cancer.
• corticosteroids, such as prednisone, cortisone.
• metoclopramide, propantelina, antidepressants with anticholinergic properties, and narcotic analgesics.
• colestiramine, a medication used to reduce elevated serum lipid levels.
• tacrolimus or cyclosporine, immunosuppressive drugs used after organ transplantation.
• sulfonylureas, a medication used to treat diabetes.
• some antibiotics (such as quinolone antibiotics or cotrimoxazole).
• cardiac glycosides, medications to strengthen the heart.
• flucloxacilina (antibiotic), due to a serious risk ofblood and fluid anomalyand requiring urgent treatment(see section 2)

Other medications may also affect or be affected by Dolostop Plus treatment. Therefore, you should always seek advice from your doctor or pharmacist before taking paracetamol/ibuprofen with other medications.

Your doctor and pharmacist will have more information about these and other medications with which you should be careful or avoid while taking this medication.

Pregnancy, breastfeeding, and fertility

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

Do not take this medication if you are in the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take this medication during the first six months of pregnancy unless it is clearly necessary and as indicated by your doctor.

If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, this medication may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

This medication may alter female fertility and is not recommended for women trying to conceive.

Driving and operating machinery

Be careful when driving or operating machinery until you know how this medication affects you.

Dolostop Plus contains lactose:

If your doctor has told you that you have intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.Do not take it for more than 3days..

The effective dose should be used for the shortest duration necessary to alleviate symptoms. If you have an infection, consult a doctor promptly if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is:

Adults:The usual dose is one tablet (500 mg of paracetamol and 150mg of ibuprofen) or two tablets (1000 mg of paracetamol and 300mg of ibuprofen) every six hours, as needed, up to a maximum of sixtablets in 24hours.

Use the effective dose for the shortest duration necessary to alleviate symptoms. You should consult a doctor if symptoms persist or worsen or if the medication is necessary for more than 3días.

Do not take more than 6 tablets in a 24hour period.

If your doctor prescribes a different dose, follow the instructions provided by the doctor.

Take this medication with a full glass of water. The groove is only for breaking the tablet and facilitating its swallowing, but not for dividing it into equal doses.

Use in children and adolescents (under 18 years)

This medicationis contraindicated in children and adolescents (under 18years).

If you take more Dolostop Plus than you should

Consult a doctor immediately if you have taken an excessive amount of this medication, even if you feel well. The reason is that an excessive amount of paracetamol can cause severe late liver damage. Do this even if you do not have signs of discomfort or intoxication. You may need urgent medical attention.

If you have taken more Dolostop Plus than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing difficulties have been reported.

If you forgot to take Dolostop Plus

If it is almost time to take the next dose, omit the missed dose and take the next dose at the scheduled time. Otherwise, take it as soon as you remember and continue taking the tablets as usual.

Do not take a double dose to compensate for the missed doses.

If you are unsure whether to omit or not the dose, talk to your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If any of the side effects worsen or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Stop taking Dolostop Plus and seek medical attention immediately if you notice any of the following symptoms:

- Flat, red, circular or target-shaped patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

- Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

- Generalized, red, scaly, and blistering rash, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

If any of these severe side effects occur, stop taking Dolostop Plus and immediately inform your doctor or visit the nearest hospital emergency department:

Frequent:

• bloody vomiting or coffee ground-like content.
• rectal bleeding, black, sticky stools, or bloody diarrhea.
• swelling of the face, lips, or tongue, which may cause difficulty swallowing or breathing.

Rare:

• asthma, wheezing, shortness of breath.
• sudden or intense itching, skin eruption, hives.
• intense rash with blisters and bleeding in the lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome). Rare cases of severe skin reactions have been reported.
• worsening of existing severe skin infections (may observe rash, blistering, skin color changes, fever, drowsiness, diarrhea, and discomfort) or worsening of other infections, including chickenpox or shingles or intense infection with tissue destruction (necrosis) and skin blistering.
• fever, general malaise, nausea, stomach pain, headache, and neck stiffness.

Other possible side effects are:

Frequent (may affect up to 1 in 10 people):

• nausea or vomiting.
• loss of appetite.
• heartburn or stomach pain.
• cramps, gas, constipation, or diarrhea, mild digestive bleeding.
• skin eruptions, itching.
• headache.
• dizziness.
• nervousness.
• ringing in the ears.
• unusual weight gain, swelling, and fluid retention, swelling of the ankles or legs (edema).

Rare (may affect up to 1 in 100 people):

• decreased red blood cells, nasal bleeding, and heavier menstrual periods.
• allergic reactions: skin eruption, fatigue, joint pain (e.g., serum disease, lupus erythematosus syndrome, Henoch-Schönlein vasculitis, angioedema).
• breast tissue enlargement in men; low blood sugar levels.
• insomnia.
• change in mood, e.g., depression, confusion, nervousness.
• eye problems, such as blurred vision (reversible), red and irritated eyes, itching.
• increased mucus thickness.
• severe stomach pain or discomfort; peptic ulcer/digestive ulcer.
• inflammation of the intestine and worsening of colon inflammation (colitis) and digestive tract inflammation (Crohn's disease), as well as complications of the large intestine diverticula (perforation or fistula).
• inability to completely empty the bladder (urinary retention).
• abnormal laboratory results (blood test and liver and kidney enzyme test results).

Rare (may affect up to 1 in 1000 people):

• tingling in the hands and feet.
• abnormal dreams, visual hallucinations.
• kidney damage (especially with prolonged use).
• elevated blood uric acid levels (hyperuricemia).

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

• low potassium levels: weakness, fatigue, muscle cramps (hypokalemia).
• signs of anemia, such as fatigue, headaches, shortness of breath, and pale appearance.
• easier bleeding or bruising, red or purple patches under the skin.
• severe headache or persistent headache.
• sensation of spinning (vertigo).
• rapid or irregular heartbeat; also known as palpitations.
• increased blood pressure and possible heart problems.
• inflammation of the esophagus.
• yellowing of the skin or eyes, also known as jaundice.
• liver damage (especially with prolonged use).
• hair loss.
• increased sweating.
• signs of frequent or concerning infections, such as fever, intense chills, sore throat, or mouth ulcers.

Not known (cannot be estimated from available data):

• a severe skin reaction known as DRESS syndrome may occur. DRESS syndrome symptoms include: skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell).
• generalized, red, scaly, and blistering rash, located mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking this medication if you experience these symptoms and seek medical attention immediately. See section 2.
• skin becomes sensitive to light.
• a severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

The above list includes severe side effects that may require medical attention. Severe side effects are rare with low doses of this medication and when used for a short period.

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de uso humano:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require any special storage temperature. Store in the original packaging type blister to protect it from light.

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

Do not use this medication if you observe that the packaging is broken or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dolostop Plus 500 mg/150 mg coated tablets

The active principles are 500 mg of paracetamol and 150 mg of ibuprofen per tablet.

The other components of the tablet core are: cornstarch, pregelatinized cornstarch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc, and in the tablet coating: Opadry white (containing hypromellose (E464), lactose monohydrate (see section 2), titanium dioxide (E171), macrogol/PEG 4000, and sodium citrate (E331)) and talc.

Appearance of Dolostop Plus and content of the container

Coated tablets of white color, in capsule shape, 19 mm in length, with a groove on one face and smooth on the other. The groove serves only to break and facilitate swallowing but not to divide into equal doses.

Each container contains 8, 10, 16, 20, 24, 30, and 32 coated tablets in blister packaging. Some container sizes may only be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

Alterno Labs d.o.o,

Brnciceva ulica 29, Ljubljana-Crnuce, 1231,

Slovenia

This medicine is authorized in the member states of the European Economic Area with the following names:

Portugal: Dolostop Duo 500 mg/150 mg coated tablets

Last review date of this leaflet: January 2025

“Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”