Amlodipine Fair-med

Package Leaflet: Information for the User

Amlodipine Fair-Med, 5 mg, tablets

Amlodipine Fair-Med, 10 mg, tablets

Amlodipine

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Amlodipine Fair-Med is and what it is used for
• 2. What you need to know before you take Amlodipine Fair-Med
• 3. How to take Amlodipine Fair-Med
• 4. Possible side effects
• 5. How to store Amlodipine Fair-Med
• 6. Contents of the pack and other information

1. What Amlodipine Fair-Med is and what it is used for

Amlodipine Fair-Med contains the active substance amlodipine which belongs to a group of medicines called calcium channel blockers. Amlodipine Fair-Med is used to treat high blood pressure (hypertension) and a type of chest pain called angina. In patients with high blood pressure, this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Amlodipine Fair-Med improves blood supply to the heart muscle, which receives more oxygen and as a result, chest pain is prevented. However, Amlodipine Fair-Med does not immediately relieve the chest pain that occurs with angina.

2. What you need to know before you take Amlodipine Fair-Med

Do not take Amlodipine Fair-Med

• If you are allergic to amlodipine or any other calcium channel blocker or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may cause swelling of the face, lips, tongue, or throat, difficulty breathing, or a severe rash.
• If you have very low blood pressure (hypotension).
• If you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to deliver enough blood to the body).
• If you have had a heart attack in the past 4 weeks.

Warnings and precautions

Before taking Amlodipine Fair-Med, tell your doctor if you have or have had:

• Recent heart attack.
• Heart failure.
• Severe increase in blood pressure (hypertensive crisis).
• Liver disease.
• Necessity to increase the dose in elderly patients.

Children and adolescents

Amlodipine Fair-Med has not been studied in children under the age of 6 years. Amlodipine Fair-Med should only be used in children and adolescents from 6 to 17 years of age for the treatment of hypertension (see section 3). For more information, talk to your doctor.

Amlodipine Fair-Med with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those you can buy without a prescription. Amlodipine Fair-Med may interact with other medicines, and other medicines may affect the way Amlodipine Fair-Med works. These include:

• Ketoconazole, itraconazole (antifungal medicines);
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection);
• Rifampicin, erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• Verapamil, diltiazem (heart medicines);
• Dantrolene (a medicine used to treat severe body temperature disturbances);
• Simvastatin (a cholesterol-lowering medicine).

Amlodipine Fair-Med may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure.

Amlodipine Fair-Med with food and drink

Patients taking Amlodipine Fair-Med should not drink grapefruit juice or eat grapefruits. This is because grapefruits and grapefruit juice can increase the levels of amlodipine in the blood, which can lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Fair-Med.

Pregnancy and breastfeeding

Pregnancy
The safety of amlodipine in human pregnancy has not been established. If you are pregnant or think you might be pregnant, or if you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding
It is not known whether amlodipine passes into breast milk. If you are breast-feeding or plan to breast-feed, talk to your doctor before taking Amlodipine Fair-Med. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amlodipine Fair-Med may affect your ability to drive or use machines. If you experience dizziness, headache, or fatigue when taking this medicine, do not drive or use machines until these effects have disappeared. If you experience any of these effects, do not drive or use machines and contact your doctor immediately.

3. How to take Amlodipine Fair-Med

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose of Amlodipine Fair-Med is 5 mg once daily. The dose can be increased to 10 mg once daily. You can take Amlodipine Fair-Med before or after food and drinks. You should take Amlodipine Fair-Med at the same time every day with a glass of water. Do not take Amlodipine Fair-Med with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years old), the recommended initial dose is 2.5 mg once daily. The maximum recommended dose is 5 mg once daily. If a 2.5 mg dose is not available, your doctor will prescribe a different product that is available on the market. It is important to keep taking this medicine as long as your doctor tells you to. If you have any questions, talk to your doctor.

If you take more Amlodipine Fair-Med than you should

Taking too many tablets may cause a severe drop in blood pressure. This can lead to dizziness, lightheadedness, or fainting. If you have taken too many tablets, contact your doctor immediately.

If you forget to take Amlodipine Fair-Med

It is not harmful if you miss a dose. If you forget to take a tablet, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amlodipine Fair-Med

Your doctor will tell you how long to take Amlodipine Fair-Med. If you stop taking this medicine without talking to your doctor, your condition may worsen. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Amlodipine Fair-Med can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, stop taking Amlodipine Fair-Med and contact your doctor immediately.

• Sudden wheezing, chest pain, difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat, which may cause difficulty breathing.
• Severe skin reactions, including widespread rash, itching, and blistering.
• Heart attack, abnormal heart rhythm.
• Pancreatitis, which may cause severe abdominal and back pain, and a feeling of being very unwell.

The following common side effectshave been reported. If any of these side effects get serious or last longer than a week, talk to your doctor.

• Headache, dizziness, tiredness (especially at the start of treatment).
• Palpitations, flushing.
• Abdominal pain, nausea.
• Swelling of the ankles, feeling tired.

Other side effects have been reported. If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

• Mood changes, anxiety, depression, insomnia.
• Trembling, taste disturbances, fainting, weakness.
• Numbness or tingling of the limbs; loss of pain sensation.
• Visual disturbances, double vision, ringing in the ears.
• Low blood pressure.
• Sneezing/runny nose caused by inflammation of the nasal mucosa.
• Abnormal gut feelings, diarrhea, constipation, indigestion, dry mouth, vomiting.
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration.
• Urination disorders, increased need to urinate at night, frequent urination.
• Impotence, discomfort, or enlargement of the breasts in men.
• Weakness, pain, feeling unwell.
• Joint or muscle pain, muscle cramps, back pain.
• Weight increase or decrease.

Rare side effects(may affect up to 1 in 1,000 people)

• Disorientation.

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

• Decreased number of white blood cells, decreased number of platelets, which may cause unusual bruising or bleeding (destruction of red blood cells).
• Increased blood sugar levels (hyperglycemia).
• Nerve disorders, which may cause weakness, numbness, or tingling.
• Cough, gum swelling.
• Abdominal bloating (gastritis).
• Abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect some medical tests.
• Increased muscle tension.
• Vasculitis (inflammation of blood vessels), often with skin rash.
• Sensitivity to light.
• Stiffness, trembling, and/or movement disturbances.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine Fair-Med

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 carton. The expiry date refers to the last day of that month. Store in the original package to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Amlodipine Fair-Med contains

• The active substance is amlodipine besylate. Each tablet contains amlodipine besylate equivalent to 5 mg amlodipine.
• The active substance is amlodipine besylate. Each tablet contains amlodipine besylate equivalent to 10 mg amlodipine.
• The other ingredients are microcrystalline cellulose, sodium carboxymethylcellulose (type A), anhydrous colloidal silica, and magnesium stearate.

What Amlodipine Fair-Med looks like and contents of the pack

5 mg tablets: white to almost white, round, uncoated, biconvex, smooth on both sides. 10 mg tablets: white to almost white, round, uncoated, biconvex, with a score line on one side, smooth on the other side. The tablet can be divided into equal doses. PVC/PVDC/Aluminum blister pack in a cardboard box. 5 mg: 30 tablets. 10 mg: 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
PharmSol Europe Limited
Victoria Centre Unit 2
Lower Ground Floor Valletta Road
Mosta, MST 9012 Malta
Manufacturer/Importer
Fairmed Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck
Germany
Fine Foods Pharmaceuticals N.M.T. S.p.A.
Via Berlino, 39
24040 Zingonia-Verdellino, BG, Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Portugal
Amlodipina Fair-Med
Austria
Amlodipin Fair-Med 5mg, 10mg Tabletten
Germany
Amlodipin Fair-Med Healthcare 5mg, 10mg Tabletten
Spain
Amlodipino Fair-Med 5mg, 10mg Comprimidos EFG
Ireland
Amlodipine Fair-Med 5mg, 10mg Tablets
Italy
Amlodipina Fair-Med
Poland
Amlodipine Fair-Med

Date of last revision of the leaflet: