Molap 6 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Molap 6 mg Film-coated Tablets
lacidipine
Read all of this leaflet carefully before you start using 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Molap is and what it is used for
2. What you need to know before you take Molap
3. How to take Molap
4. Possible side effects
5. How to store Molap
6. Content of the pack and other information
1. WHAT MOLAP IS AND WHAT IT IS USED FOR
Molap contains a medicine called lacidipine. This belongs to a group of medicines called 'calcium channels blockers'. Molap helps to relax your blood vessels so that they get wider. This helps the blood to flow more easily and lowers the blood pressure.
Molap taken regularly as prescribed by your doctor will help to lower your blood pressure (to treat hypertension).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOLAP Do not take Molap:
• If you are allergic to lacidipine, other calcium channel blocker medicines or any of the other ingredients of this medicine (listed in section 6).
• If you have the heart problem 'aortic stenosis'. This is a narrowing of a valve in your heart, which restricts blood blow.
• If you have had a heart attack within the last month and in case of severe heart failure.
• You should stop taking lacidipine if you get chest pain (angina) or a fast, weak pulse, rapid shallow breathing, low blood pressure, cold clammy skin, blue lips or feel dizzy, faint, weak or sick.
Do not take Molap if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Molap.
Warning and precautions
Check with your doctor or pharmacist before taking your medicine:
- If you have an uneven heart beat or any other heart problems
- If you have or have ever had any liver problems
Other medicines and Molap
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Molap can affect the way some other medicines work. Also some other medicines can affect the way Molap works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Medicines for high blood pressure
• Medicines for the treatment of fungal infections
• Medicines to control your heart beat (called 'anti-arrhythimcs)
• Medicines for depression called 'tricyclic antidepressants'
• Antibiotics (eg. rifampicin)
• Medicines for the treatment of epilepsy
• Cimetidine - used for stomach problems
• Ciclosporin (eg immunosuppressive drugs administered to recipients of organ donors after a transplant)
• Steroids or tetracosactide (used for the treatment of inflammatory conditions such as asthma, ulcerative colitis or arthritis)
If you are having any blood tests, tell the person giving the test that you are taking this medicine. This is because Molap can affect results relating to your liver.
Molap with food, drink and alcohol
You can take this medicine on an empty stomach or with food.
Discuss with your doctor if it is appropriate for you to have alcohol whilst taking this medicine since alcohol may increase the effects of lacidipine.
Do not take this medicine with grapefruit juice.
Pregnancy, breast-feeding and fertility
If you are pregnancy or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine may impair male fertility.
Driving and using machines
This medicine may cause dizziness. If you experience this side effect, do not drive vehicles or operate machines which require your attention.
Molap contains Lactose Monohydrate. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
3. HOW TO TAKE MOLAP
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
It is important to take the right number of tablets at the right time of day.
• The recommended starting dose is 2 mg every morning.
• After 3-4 weeks this may be increased to 4 mg every morning.
• If necessary the dose may be increased again to 6 mg every morning which is the maximum daily dose.
• Swallow the tablets whole with a drink of water.
• Do not take with grapefruit juice.
If you take more Molap than you should
If you take more of this medicine than you should talk to a doctor or go to a hospital straight away. Take the medicine pack with you, even if there are no tablets left.
Medical treatment can be necessary. Effects of overdose will likely cause irregular heartbeat, rapid shallow breathing, low blood pressure, cold humid skin or feeling dizzy, fainting, weakness or nausea.
If you forget to take Molap
If you forget a dose in the morning, take it as soon as you remember it on the same day. However, if you remember the next day, take your normal dose on that morning. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, please contact your doctor or pharmacist.
Bozza no.: 6 / Recto Data: 15.03.16 Colore: Nero Lineagrafica sa
Codice: Molap 6 mg Film-coated Tablets RIVO UK Formato: mm 190 x 240 6596 Gordola
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you have any of the following side effects:
• Chest pain (angina) including chest pain which gets worse.
• You become severely unwell with a rapid pulse, sweating, breathlessness and faintness.
Common (may affect up to 1 in 10 people)
• Headache
• Dizziness
• Flushing
• Fast or irregular heart beat (palpitations)
• Upset stomach or nausea
• Rash, redness of the skin, itching
• An increase in the amount of urine
• Feeling weak
• Swelling particularly on the ankles
• Changes in results of blood tests relating to your liver
Uncommon (may affect up to 1 in 100 people)
• Low blood pressure for example feeling faint, fainting
• Swelling of the gums
Rare (may affect up to 1 in 1,000 people)
• Angioedema (allergic reaction that causes swelling of the face)
• Skin rash with itching (hives/urticaria)
• Muscle cramps
Very rare (may affect up to 1 in 10,000 people)
• Tremor
• Depression
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 Yellow Card Scheme at: 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 MOLAP
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light.
Do not use Molap after the expiry date which is stated on the carton and the blister foil. The expiry date refers to the last day of that month.
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 Molap contains
- The active substance is lacidipine. Each tablet contains 6 mg of active substance lacidipine.
- The other ingredients are lactose monohydrate, povidone and magnesium stearate. The film coating contains hypromellose and titanium dioxide.
What Molap looks like and contents of the pack
Molap 6 mg Film-coated Tablets are white, ovoidal, biconvex tablets embossed with '6' on one side.
They are available in Aluminium/Aluminium blister packs of 14, 28 film-coated tablets.
Not all pack sizes may be marketed
Marketing authorisation holder and Manufacturers
Marketing Authorisation Holder Rivopharm UK Ltd 30th Floor, 40 Bank Street Canary Wharf London E14 5NR, UK
Manufacturers Laboratories BTT ZI de Krafft 67150 Erstein France
Rivopharm UK Ltd 30th Floor, 40 Bank Street Canary Wharf London E14 5NR, UK