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. 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 angina (a type of chest pain).
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. Before you take Amlodipine Fair-Med

When not to take Amlodipine Fair-Med

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may cause itching, redness of the skin, or difficulty breathing.
• 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 supply enough blood to the body).
• If you have had a heart attack and have heart failure.

Warnings and precautions

Before taking Amlodipine Fair-Med, tell your doctor, pharmacist, or nurse if you have or have had any of the following conditions:

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

Children and adolescents

There is limited experience with the use of Amlodipine Fair-Med in children, and the safety and efficacy of amlodipine in children under 6 years old have not been established.
Amlodipine Fair-Med should only be used in pediatric patients with hypertension aged 6–17 years (see section 3).
For more information, consult your doctor.

Amlodipine Fair-Med with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, and about any medicines you plan to take.
Amlodipine Fair-Med may interact with other medicines, and other medicines may interact with Amlodipine Fair-Med. 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 enhance 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 the active substance (amlodipine) in the blood, which can lead to an unpredictable increase in the effect of Amlodipine Fair-Med in lowering blood pressure.

Pregnancy and breastfeeding

Pregnancy
The safety of amlodipine in pregnancy has not been established. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
It is not known whether amlodipine passes into breast milk. Breastfeeding mothers should consult their 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 operate machinery.
If you experience dizziness, headache, tiredness, or nausea while taking Amlodipine Fair-Med, do not drive or operate machinery and consult 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 of Amlodipine Fair-Med can be increased to 10 mg once daily.
Amlodipine Fair-Med can be taken before or after food and drink. Take the medicine 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

In children and adolescents (aged 6-17 years), the recommended initial dose is 2.5 mg once daily.
The maximum recommended dose is 5 mg once daily.
For the 2.5 mg dose (currently not available), the patient should receive an alternative product available on the market.
It is important to continue taking the medicine as long as prescribed by your doctor. Consult your doctor before finishing the pack.

If you take more Amlodipine Fair-Med than you should

Taking too many tablets may cause a significant and potentially serious drop in blood pressure. You may experience dizziness, lightheadedness, or fainting.
In severe cases, a drop in blood pressure may lead to shock. Your skin may become cool and clammy, and you may lose consciousness. If you take too much Amlodipine Fair-Med, contact your doctor immediately.

If you forget to take Amlodipine Fair-Med

It is not dangerous. If you forget to take a tablet, skip it 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 the medicine without consulting your doctor, your symptoms may return.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical attention if you experience any of the following very rare but serious side effects after taking this medicine.

• Sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue or throat, which may cause severe difficulty breathing.
• Severe skin reactions, including widespread rash, itching, or hives, redness of the skin, severe itching, blistering, peeling, or swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions.
• Heart attack, irregular heartbeat.
• Pancreatitis, which may cause severe abdominal and back pain, and a very bad general feeling.

The following common side effectshave been reported. If any of these side effects bother you or persist for more than a week, consult your doctor.
Common side effects:may affect up to 1 in 10 people

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

Other side effects that have been reported include:
Uncommon side effects:may affect up to 1 in 100 people

• 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 sensations, diarrhea, constipation, indigestion, dry mouth, vomiting.
• Hair loss, increased sweating, itching, redness of the skin, skin discoloration.
• Urinary disturbances, increased need to urinate at night, frequent urination.
• Impotence, discomfort, or enlargement of the breasts in men.
• Weakness, pain, or malaise.
• Joint or muscle pain, muscle cramps, back pain.
• Weight gain or loss.

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 white blood cell count, decreased platelet count, 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 overgrowth.
• 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 tone.
• Vasculitis, often with skin rash.
• Sensitivity to light.
• Stiffness, trembling, and/or movement disturbances.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can also be reported directly to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
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 packaging. The expiry date refers to the last day of that month.
Store in the original package to protect from light.
Do not throw away any medicines 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 of amlodipine.
• The active substance is amlodipine besylate. Each tablet contains amlodipine besylate equivalent to 10 mg of 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: