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Ramipril/Amlodipine Apotex

Document: Ramipril_Amlodipine Apotex capsule, hard ENG PL change

Package leaflet: Information for the patient


Ramipril/Amlodipine Apotex, 5 mg/5 mg, capsule, hard

Ramipril/Amlodipine Apotex, 5 mg/10 mg, capsule, hard

Ramipril/Amlodipine Apotex, 10 mg/5 mg, capsule, hard

Ramipril/Amlodipine Apotex, 10 mg/10 mg, capsule, hard


Ramipril/Amlodipine


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

- 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 Ramipril/Amlodipine Apotex is and what it is used for

2. What you need to know before you take Ramipril/Amlodipine Apotex

3. How to take Ramipril/Amlodipine Apotex

4. Possible side effects

How to store Ramipril/Amlodipine Apotex

6. Contents of the pack and other information


What Ramipril/Amlodipine Apotex is and what it is used for


Ramipril/Amlodipine Apotex contains two active substances: ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). Amlodipine belongs to a group of medicines called calcium antagonists.


Ramipril works by:


Amlodipine works by:

Relaxing and widening blood vessels, so that blood passes through them more easily.


Ramipril/Amlodipine Apotex is used to treat hypertension (high blood pressure), in patients whose blood pressure is adequately controlled with amlodipine and ramipril given concurrently at the same dose level as in Ramipril/Amlodipine Apotex, but as a separate medicines.


What you need to know before you take Ramipril/Amlodipine Apotex


Do not take Ramipril/Amlodipine Apotex:

- if you are allergic to ramipril, amlodipine (active substances), other ACE inhibitor medicines or any other calcium antagonists, or any of the other ingredients of this medicine (listed in section 6). This may be itching, reddening of the skin or difficulty in breathing.


Do not take Ramipril/Amlodipine Apotex if any of the above apply to you. If you are not sure, talk to your doctor before taking Ramipril/Amlodipine Apotex.


Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril/Amlodipine Apotex. Tell your doctor, if any of the situations listed below is applicable to you:

- If you are elderly and your dose needs to be increased


If you suffer from sudden swelling of the lips and face, tongue and throat, neck, possibly also hands and feet, difficulty to swallow or to breathe, hives or hoarseness (‘angioedema’). This could be a sign of a severe allergic reaction. This may occur at any time during the treatment. Persons with black skin may have a higher risk of suffering from this condition. If you develop such symptoms you should let your doctor know immediately.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Ramipril/Amlodipine Apotex”.


Children and adolescents

Ramipril/Amlodipine Apotex is not recommended for use in children and adolescents below 18 years of age because there is no information available in this population.


Other medicines and Ramipril/Amlodipine Apotex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change your dose and/or to take other precautions:

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Ramipril/Amlodipine Apotex” and “Warnings and precautions”.


Tell your doctor if you are taking any of the following medicines. They can make Ramipril/Amlodipine Apotex work less well:


Tell your doctor if you are taking any of the following medicines. They can increase the chance of getting side effects if you take them with Ramipril/Amlodipine Apotex:


Please tell your doctor if you are taking any of the following medicines. They may be affected by Ramipril/Amlodipine Apotex:


If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril/Amlodipine Apotex.


Ramipril/Amlodipine Apotex with food,drink and alcohol

Ramipril/Amlodipine Apotex may be taken with or without food.

Drinking alcohol with Ramipril/Amlodipine Apotex may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril/Amlodipine Apotex, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.

Grapefruit juice or grapefruit should not be consumed by people who are taking Ramipril/Amlodipine Apotex. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Ramipril/Amlodipine Apotex.


Pregnancy and breast-feeding and fertility


If you are pregnant 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.


Pregnancy

You must not take Ramipril/Amlodipine Apotex during pregnancy.

If you become pregnant while on Ramipril/Amlodipine Apotex, tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.


Breast-feeding

You should not take Ramipril/Amlodipine Apotex if you are breastfeeding.

You should talk to your doctor or pharmacist before taking any medicine.


Fertility

There is no sufficient data regarding the potential effect on fertility.


Driving and using machines

Ramipril/Amlodipine Apotex may affect your ability to drive or use machines. If the Ramipril/Amlodipine Apotex make you feel sick, dizzy or tired, or give you a headache, do not drive or use machines and contact your doctor immediately. This can happen especially at the start of treatment, or when changing over from other preparations.


How to take Ramipril/Amlodipine Apotex


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you have the impression that the effect of Ramipril/Amlodipine Apotex is too strong or too weak, talk to your doctor or pharmacist.


Take this medicine by mouth at the same time of the day, before or after your meal.

Swallow the whole capsule with liquid.

Do not take Ramipril/Amlodipine Apotex with grapefruit juice.

Ramipril/Amlodipine Apotex should be administered once a day.

The doctor may modify the dose, depending on the effect it will have on you.

The maximum daily dose is one capsule 10 mg/10 mg.


Elderly

Your doctor will reduce the initial dose and adjust your treatment more slowly.


Use in children and adolescents

Ramipril/Amlodipine Apotex is not recommended for use in children and adolescents below 18 years of age because there is no information available in this population.


If you take more Ramipril/Amlodipine Apotex than you should

Taking too many capsules may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Tell a doctor or go to the nearest hospital casualty department straight away. Do not drive to the hospital, get somebody else to take you or call for an ambulance. Take the medicine pack with you. This is so the doctor knows what you have taken.


If you forget to take use Ramipril/Amlodipine Apotex

If you forget to take a capsule, leave out that dose completely. Take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.


If you stop taking Ramipril/Amlodipine Apotex

Your doctor will advise you how long to take your medicine. Your condition may return if you stop using your medicine before you are advised.


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.


Stop taking Ramipril/Amlodipine Apotex and see a doctor straight away, if you notice any of the following serious side effects – you may need urgent medical treatment:

The frequencies of the above mentioned side effects are classified as not known (cannot be estimated from the available data)


Tell your doctor immediately if you experience:


Other side effects include:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.


Common (may affect up to 1 in 10 people):


Uncommon (may affect up to 1 in 100 people):

Mood changes, sleeplessness


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


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


Other side effects reported:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Ramipril/Amlodipine Apotex


Store below 30°C.

Store in the original package in order to protect from light.


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 and blister pack after EXP. 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 Ramipril/Amlodipine Apotex contains

The active substances are:

5 mg/5 mg, capsule, hard:

each capsule contains 5 mg ramipril and amlodipine besilate equivalent to 5 mg amlodipine.

5 mg/10 mg, capsule, hard:

each capsule contains 5 mg ramipril and amlodipine besilate equivalent to 10 mg amlodipine.

10 mg/5 mg, capsule, hard:

each capsule contains 10 mg ramipril and amlodipine besilate equivalent to 5 mg amlodipine.

10 mg/10 mg, capsule, hard:

each capsule contains 10 mg ramipril and amlodipine besilate equivalent to 10 mg amlodipine.


The other ingredients are: cellulose microcrystalline, calcium hydrogen phosphate, anhydrous, mazize starch, pregelatinised, sodium starch glycolate (type A), sodium stearyl fumarate, iron oxide red (E 172), titanium dioxide (E 171), gelatine, iron oxide yellow (E 172) (10 mg/10 mg), iron oxide black (E 172) (10 mg/10 mg)


What Ramipril/Amlodipine Apotex looks like and contents of the pack

Ramipril/Amlodipine Apotex5 mg/5 mg, capsule, hard: hard gelatine capsules, cap: opaque pink colour, body: opaque white colour. Content of capsules: white or almost white powder.

Ramipril/Amlodipine Apotex5 mg/10 mg, capsule, hard: hard gelatine capsules, cap: opaque red - brown colour, body: opaque white colour. Content of capsules: white or almost white powder.

Ramipril/Amlodipine Apotex10 mg/5 mg, capsule, hard: hard gelatine capsules, cap: opaque dark pink colour, body: opaque white colour. Content of capsules: white or almost white powder.

Ramipril/Amlodipine Apotex10 mg/10 mg, capsule, hard: hard gelatine capsules, cap: opaque brown colour, body: opaque white colour. Content of capsules: white or almost white powder.


Ramipril/Amlodipine Apotex are available in blister packs containing 28, 30, 32, 56, 60, 90, 91, 96, 98 or 100 capsules.

Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


Marketing Authorisation Holder

{To be completed nationally}


Manufacturer

{To be completed nationally}


<This medicinal product is authorised in the Member States of the EEA under the following names:>


<{Name of the Member State}> <{Name of the medicinal product}>

<{Name of the Member State}> <{Name of the medicinal product}>


This leaflet was last revised in 8 January 2015


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