Patient Information Leaflet

Felodipine Sandoz 5 mg prolonged-release tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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.

1. What Felodipine Sandoz is and what it is used for.

2. What you need to know before taking Felodipine Sandoz.

3. How to take Felodipine Sandoz.

4. Possible side effects.

5. Storage of Felodipine Sandoz.

6. Contents of the pack and additional information.

Felodipino Sandoz contains the active ingredient felodipine. This belongs to a group of medicines called calcium antagonists. It reduces blood pressure by dilating small blood vessels. It does not negatively affect heart function.

Felodipino Sandozis used for the treatment of high blood pressure (hypertension) and chest pain caused by, for example, exercise or stress (angina pectoris).

Do not take Felodipino Sandoz:

• if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6),
• if you have had an acute myocardial infarction (heart attack),
• if you have recent chest pain or angina that lasts more than 15 minutes or is more intense than usual,
• if you have uncompensated heart failure,
• if you have heart valve disease or heart muscle disease, until you have consulted your doctor,
• if you are pregnant. Inform your doctor as soon as possible if you become pregnant while taking this medicine.

Warnings and precautions

Felodipino Sandoz, like other medicines that lower blood pressure, can occasionally cause a marked decrease in blood pressure that may lead to inadequate blood supply to the heart in some patients. Symptoms of excessively low blood pressure and inadequate blood supply to the heart itself, which are often present, include dizziness and chest pain. If you experience these symptoms, contact emergency services immediately.

Consult your doctor before starting to take felodipine, especially if you have liver problems.

Taking Felodipino Sandoz may cause your gums to swell. Practice good oral hygiene to prevent gum swelling (see section 4).

Children

Felodipino Sandoz is not recommended for use in children.

Taking Felodipino Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.Some medicines/herbal remedies may affect felodipine treatment.

Some examples are:

• cimetidine (medicine for treating stomach ulcers),
• erythromycin (medicine for treating infections),
• itraconazole (medicine for treating fungi),
• ketoconazole (medicine for treating fungi),
• medicines for treating HIV - protease inhibitors (such as ritonavir),
• medicines for treating HIV infection (such as efavirenz, nevirapine),
• phenytoin (medicine for treating epilepsy),
• carbamazepine (medicinefortreating epilepsy),
• rifampicin (medicine for treating infections),
• barbiturates (medicines for treating anxiety, sleep disturbances, and epilepsy),
• tacrolimus (medicine used in organ transplants).

Medicines containing St. John's Wort (Hypericum perforatum) (herbal remedy used to treat depression) may reduce the effects of felodipine and should therefore be avoided.

Taking Felodipino Sandoz with food and drinks

Do not drink grapefruit juice while being treated with felodipine, as this may increase the effect of felodipine and the risk of adverse reactions.

Pregnancy and breastfeeding

Pregnancy

Do not use felodipino Sandoz if you are pregnant.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding.Felodipino Sandozis not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed.

Driving and operating machines

Felodipino Sandozmay have a slight or moderate influence onyour abilityto drive or operate machines. If you experience headaches, nausea, dizziness, or fatigue, your reaction time may be impaired. It is recommended to exercise caution, especiallyat thestartof treatment.

Felodipino Sandoz contains sodium and lactose

This medicine contains less than 23 mg of sodium (1 mmol) per prolonged-release tablet; this is, essentially “sodium-free”.

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

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

Felodipine Sandoz prolonged-release tablets should be taken in the morning and swallowed with water. The tablet should not be divided, crushed, or chewed. This medication can be taken on an empty stomach or with a light, low-fat, or low-carbohydrate meal.

Hypertension

The treatment should be initiated with 5 mg once a day. If necessary, your doctor may increase the dose or add another medication to lower blood pressure. The usual dose for the treatment of this disease over long periods is 5 to 10 mg once a day. In elderly patients, a starting daily dose of 2.5 mg may be considered.

A dose of 2.5 mg should be used with a medication of the appropriate concentration.

Stable Angina Pectoris

The treatment should be initiated with 5 mg once a day and, if necessary, your doctor may increase the dose to 10 mg once a day.

If You Have Liver Problems

The concentrations of the medication in the blood may increase. Your doctor may reduce your dose.

Elderly

Your doctor may initiate treatment with the lowest available dose.

If You Take More Felodipine Sandoz Than You Should

If you have taken more felodipine than you should, you may experience very low blood pressure and sometimes palpitations, rapid or, rarely, slow heart rate. It is very important that you take the dose prescribed by your doctor. If you experience symptoms such as weakness, slight dizziness, or vertigo, consult your doctor immediately, your pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If You Forget to Take Felodipine Sandoz

If you forget to take a tablet, omit the dose completely. Take the next dose at the correct time. Do not take a double dose to compensate for the missed doses.

If You Interrupt Treatment with Felodipine Sandoz

If you interrupt treatment with this medication, your disease may reappear. Consult your doctor and ask for advice before stopping the medication. Your doctor will inform you about how long you should take the medication.

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

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

If you experience any of the following, stop taking felodipine Sandoz and contact your doctor immediately:

• allergic reactions and hypersensitivity: symptoms may include skin lumps (hives) or swelling of the face, lips, mouth, tongue, or throat.

The following side effects have been identified. Most of these side effects appear at the beginning of treatment or after a dose increase. If these reactions occur, they are generally transient and decrease in intensity over time. If you experience any of the following persistent symptoms, please inform your doctor.

A mild swelling of the gums has been reported in patients with mouth inflammation (gingivitis/periodontitis). Swelling can be prevented or reversed by careful oral hygiene.

Very common:may affect more than 1 in 10 people

• swelling of the ankles.

Common:may affect up to 1 in 10 people

• redness,
• headache.

Uncommon:may affect up to 1 in 100 people

• abnormally fast heart rate,
• palpitations,
• low blood pressure (hypotension),
• nausea,
• abdominal pain,
• burning/tingling/numbness,
• eruption or itching,
• fatigue,
• dizziness.

Rare:may affect up to 1 in 1,000 people

• urticaria,
• syncope,
• vomiting,
• joint pain,
• muscle pain,
• impotence/sexual dysfunction.

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

• gingivitis (inflamed gums),
• increased liver enzymes,
• skin reactions due to sun hypersensitivity,
• inflammation of the skin capillaries,
• frequent urination,
• hypersensitivity reactions such as fever or inflammation of the lips or tongue.

Other side effects may occur. If you experience any unpleasant or unusual reaction while taking felodipine Sandoz, contact your doctor immediately.

Reporting of 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 theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medication out of the sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Composition of Felodipino Sandoz

• The active ingredient is felodipine . Each prolonged-release tablet contains 5 mg of felodipine.
• The other components are: lactose monohydrate, microcrystalline cellulose, hydroxypropylmethylcellulose, magnesium stearate, sodium lauryl sulfate, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and contents of the packaging

Felodipino Sandoz are prolonged-release tablets of reddish to reddish-gray color, round, biconvex, approximately 7 mm in diameter, with an imprint of "F5" on one of its faces.

The prolonged-release tablets are packaged in PVC/Aluminum blisters within a cardboard box.

Packaging sizes: 10, 20, 28, 30, 50, 56, 100 and 100x1 prolonged-release tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma Gmbh

Otto Von Guericke Alle, 1

D-39179 Barleben

Germany

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

Germany FELODIPIN SANDOZ 5 MG Retardtabletten

Last review date of this leaflet: January 2020

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