Felodipine Sandoz 5 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Felodipine Sandoz 5 mg prolonged-release tablets

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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. How to store Felodipine Sandoz.
6. Contents of the pack and other information.

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

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

Felodipino Sandoz is used to treat high blood pressure (hypertension) and chest pain caused, for example, by exercise or stress (angina pectoris).

2. What you need to know before taking Felodipine Sandoz

Do not take Felodipine Sandoz:

• if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6),
• if you have acute myocardial infarction (heart attack),
• if you have newly developed chest pain or angina lasting more than 15 minutes or more, or if it is more severe than usual,
• if you have uncompensated heart failure,
• if you have heart valve disease or cardiomyopathy, until you have consulted your doctor,
• if you are pregnant. You must inform your doctor as soon as possible if you become pregnant while taking this medicine.

Warnings and precautions

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

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

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

Children

The use of Felodipine Sandoz is not recommended in children.

Taking Felodipine Sandoz with other medicines

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

Some examples are:

• cimetidine (a medicine used to treat gastric ulcers),
• erythromycin (a medicine used to treat infections),
• itraconazole (a medicine used to treat fungal infections),
• ketoconazole (a medicine used to treat fungal infections),
• medicines for the treatment of HIV – protease inhibitors (such as ritonavir),
• medicines for the treatment of HIV infection (such as efavirenz, nevirapine),
• phenytoin (a medicine used to treat epilepsy),
• carbamazepine (a medicine used to treat epilepsy),
• rifampicin (a medicine used to treat infections),
• barbiturates (medicines used to treat anxiety, sleep disorders, and epilepsy),
• tacrolimus (a medicine used in organ transplantation).

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

Taking Felodipine Sandoz with food and drink

Do not drink grapefruit juice if you are 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 Felodipine Sandoz if you are pregnant.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Felodipine Sandoz is not recommended for nursing mothers and your doctor may choose an alternative treatment for you if you wish to breastfeed.

Driving and use of machines

Felodipine Sandoz may have negligible or moderate influence on the ability to drive or use machines. If you experience headache, nausea, dizziness, or fatigue, your reaction ability may be impaired. Caution is advised, especially at the beginning of treatment.

Felodipine 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 informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Felodipine Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

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

Hypertension

Treatment should be started at a dose of 5 mg once daily. If necessary, your doctor may increase the dose or add another medicine to lower blood pressure. The usual maintenance dose for long-term treatment of this condition is 5 to 10 mg once daily. In elderly patients, a starting daily dose of 2.5 mg may be considered.

For the 2.5 mg dose, a medicine with the appropriate strength should be used.

Stable angina

Treatment should be started at 5 mg once daily. If necessary, your doctor may increase the dose to 10 mg once daily.

If you have liver problems

Drug concentrations in the blood may increase. Your doctor may reduce your dose.

Elderly patients

Your doctor may start 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, increased heart rate, or rarely, slow heart rate. Therefore, it is very important that you take the dose prescribed by your doctor. If you experience symptoms such as weakness, mild dizziness, or vertigo, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Felodipine Sandoz

If you forget to take a dose, skip the missed dose completely. Take the next dose at the regular time. Do not take a double dose to make up for a missed dose.

If you stop taking Felodipine Sandoz

If you stop treatment with this medicine, your condition may recur. Consult your doctor and seek advice before stopping felodipine. Your doctor will inform you how long you should continue taking the medicine.

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

4. Possible adverse effects

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

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

• Hypersensitivity and allergic reactions: signs may include skin lumps (wheals) or swelling of the face, lips, mouth, tongue, or throat.

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

A slight swelling of the gums has been reported in patients with inflammation in the mouth (gingivitis/periodontitis). The 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

• flushing,
• headache.

Uncommon: may affect up to 1 in 100 people

• abnormally fast heartbeat,
• palpitations,
• blood pressure too low (hypotension),
• nausea,
• abdominal pain,
• burning/stinging/tingling,
• rash or itching,
• fatigue,
• dizziness.

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

• urticaria,
• fainting,
• 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 hypersensitivity to sunlight,
• inflammation of the skin's blood capillaries,
• frequent need to urinate,
• hypersensitivity reactions such as fever or swelling of the lips or tongue.

Other adverse effects may occur. If you have any bothersome or unusual reaction while taking felodipine Sandoz, contact your doctor immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Felodipine Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Felodipine Sandoz

• The active substance is felodipine. Each prolonged-release tablet contains 5 mg of felodipine.
• The other components are: monohydrate lactose, microcrystalline cellulose, hypromellose, 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 pack contents

Felodipine Sandoz prolonged-release tablets are reddish to greyish-red in colour, round, biconvex, approximately 7 mm in diameter, with the imprint "F5" on one side.

The prolonged-release tablets are packed in PVC/aluminum blisters within a cardboard box.

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto Von Guericke Allee, 1

D-39179 Barleben

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: FELODIPIN SANDOZ 5 MG Retardtabletten

Date of the most recent review of this leaflet: January 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/