FELODIPINE SANDOZ 5 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take 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 had a heart attack (myocardial infarction),
• if you have recently developed chest pain or angina pectoris that lasts more than 15 minutes or is more severe than usual,
• if you have unstable heart failure,
• if you have a heart valve or heart muscle disease, unless you have consulted your doctor,
• if you are pregnant. You should inform your doctor as soon as possible if you become pregnant while taking this medicine.

Warnings and precautions

Felodipine Sandoz, like other blood pressure-lowering medicines, can occasionally cause a marked decrease in blood pressure, which can lead to inadequate blood supply to the heart in some patients. Symptoms of low blood pressure and inadequate blood supply to the heart often include dizziness and chest pain. If you experience these symptoms, contact emergency services immediately.

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

Taking Felodipine Sandoz can cause gum swelling. Practice good oral hygiene to prevent gum swelling (see section 4).

Children

Felodipine Sandoz is not recommended for use in children.

Taking Felodipine Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines/plants can affect treatment with felodipine.

Some examples are:

• cimetidine (medicine for the treatment of stomach ulcers),
• erythromycin (medicine for the treatment of infections),
• itraconazole (medicine for the treatment of fungal infections),
• ketoconazole (medicine for the treatment of 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 (medicine for the treatment of epilepsy),
• carbamazepine (medicine for the treatment of epilepsy),
• rifampicin (medicine for the treatment of infections),
• barbiturates (medicines for the treatment of anxiety, sleep disorders, and epilepsy),
• tacrolimus (medicine used in organ transplants).

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

Taking Felodipine Sandoz with food and drinks

Do not drink grapefruit juice if you are being treated with felodipine, as this can 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

Tell your doctor if you are breastfeeding or plan to start breastfeeding. Felodipine Sandoz is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed.

Driving and using machines

Felodipine Sandoz may have a minor to moderate influence on the ability to drive and use machines. If you experience headache, nausea, dizziness, or fatigue, your reaction time may be impaired. It is recommended to be cautious, especially at the start 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 told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Felodipine Sandoz

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, 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 medicine can be taken on an empty stomach or with a light, low-fat meal.

Hypertension

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

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

Stable angina pectoris

Treatment should be started with 5 mg once daily, and if necessary, your doctor may increase the dose to 10 mg once daily.

If you have liver problems

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

Elderly

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, rapid heart rate, or, rarely, slow heart rate. Therefore, it is very important to take the dose prescribed by your doctor. If you experience symptoms such as weakness, slight dizziness, or vertigo, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Felodipine Sandoz

If you forget to take a tablet, skip the dose completely. Take the next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking Felodipine Sandoz

If you stop treatment with this medicine, your illness may recur. Consult your doctor and ask for advice before stopping felodipine. Your doctor will tell you how long you should take the medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 (hives) or swelling of the face, lips, mouth, tongue, or throat.

The following side effects have been identified. Most of these effects appear at the start of treatment or after a dose increase. 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 mouth inflammation (gingivitis/periodontitis). The swelling can be avoided 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

• abnormal heart rhythm,
• palpitations,
• low blood pressure (hypotension),
• nausea,
• abdominal pain,
• burning/stinging/tingling,
• rash or itching,
• fatigue,
• dizziness.

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

• hives,
• 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 blood vessels in the skin,
• need to urinate frequently,
• hypersensitivity reactions such as fever or inflammation of the lips or tongue.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Felodipine Sandoz

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Felodipine Sandoz

• The active substance is felodipine. Each prolonged-release tablet contains 5 mg of felodipine.
• The other ingredients are: lactose monohydrate, 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 and packaging

Felodipine Sandoz are prolonged-release tablets, reddish to reddish-grey in color, round, biconvex, approximately 7mm in diameter, with an imprint "F5" on one side.

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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 under the following names:

Germany FELODIPIN SANDOZ 5 MG Retardtabletten

Date of last revision of this leaflet: January 2020

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