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Unimax Mite

Document: Unimax and Unimax mite prolonged-release tablet ENG PL change

PACKAGE LEAFLET: INFORMATION FOR THE USER


Unimax mite 2.5 mg / 2.5 mg and Unimax 5 mg / 5 mg

prolonged release tablets

ramipril/felodipine

Read all of this leaflet carefully before you start 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 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 Unimax mite and Unimax are and what they are used for

2. What you need to know before you take Unimax mite or Unimax

3. How to take Unimax mite or Unimax

4. Possible side effects

How to store Unimax mite and Unimax

6. Contents of the pack and other information


What unimax mite and unimax are and what they are used for


Unimax mite 2.5 mg / 2.5 mg and Unimax 5 mg / 5 mg prolonged release tablets (called also Unimax tablets in this leaflet) both contain two medicines called ramipril and felodipine.


Unimax tablets is used to treat high blood pressure (hypertension).
Unimax tablets should be used in patients whose blood pressure is not adequately controlled on felodipine or ramipril alone.


What you need to know before you take unimax mite or unimax


Do not take Unimax tablets if:

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Unimax tablets


Warnings and precautions:

Talk to your doctor or pharmacist before taking Unimax mite or Unimax:


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 Unimax tablets”.


If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Unimax tablets.


Other medicines and Unimax mite and Unimax

Tell your doctor or pharmacist if you are using, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Unimax tablets can affect the way some other medicines work. Also some medicines can affect the way Unimax tablets work.


Your doctor may need to change your dose and/or take other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the heading “Do not take Unimax tablets” and “Warnings and precautions”).


In particular, tell your doctor if you are taking or being treated with any of the following:

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Unimax tablets.


Unimax mite and Unimax with food and drink


Pregnancy and breast-feeding

Do not take Unimax tablets if:

If you suspect you have become pregnant while taking Unimax tablets, you should talk to your doctor immediately.


Ask your doctor or pharmacist for advice before taking any medicine.


Driving and using machines

You may feel dizzy or light-headed after taking this medicine and it may lower your ability to concentrate and react. If this happens, do not drive or use any tools or machines.


Unimax tablets contain lactose, a type of sugar, and hydrogenated castor oil. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.

Hydrogenated castor oil may cause stomach upset or diarrhea.


How to take Unimax mite or Unimax


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

Unimax mite and Unimax are for adults only. Do not give to children.


Taking this medicine


How much to take


If you take more Unimax mite or Unimax than you should

If you take more Unimax mite or Unimax than you should, tell a doctor or go to the nearest hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. You may feel dizzy and light-headed because your blood pressure is too low.


If you forget to take Unimax mite or Unimax


If you forget to take a dose and remember on the same day:


If you forget to take a dose and remember this the next day:


If you stop taking Unimax mite or Unimax

Keep taking treatment until your doctor tells you to stop. Do not stop taking this medicine just because you feel better. If you stop, your blood pressure may rise again.


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. Some of these effects may be serious and may require medical attention.


Tell your doctor immediately and stop taking Unimax tablets if you notice any of the following – you may need urgent medical treatment:

Tell your doctor immediately if you notice any of the following:


The following side effects have been reported:


Very common side effects (may occur in ≥ 10 patients in 100)

Swollen arms and legs

Commonside effects(may occur in 1 to 10 patients in 100)

Uncommon side effects (may occur in 1 to 10 patients in 1,000)

Loss or change in the way things taste

Worsening of asthma

Being less interested in sex than usual, impotence in men

Blood tests may show changes in the way your liver, pancreas or kidneys are working

Blood tests showing more of a certain kind of white blood cells (eosinophilia) in your blood

Rare side effects (may occur in 1 to 10 patients in 10,000)

Very rare side effects (may occur in less than 1 in 10,000 patients)

Blood tests showing more sugar than usual in your blood

Not known (frequency cannot be estimated from available data)

Blood tests showing more of substances called ‘antinuclear antibodies’ in your blood


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 Appendix V. By reporting side effects you can help provide more information on the

safety of this medicine.


5. How to store Unimax mite and Unimax

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 after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C 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 Unimax mite and Unimax contain



What Unimax mite and Unimax look like and contents of the pack

Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


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

Germany UNIMAX
Greece UNITENS
Finland UNIMAXMITE, UNIMAX
Sweden UNIMAX MITE, UNIMAX


This leaflet was last approved in 18 February 2015


BLUE BOX FOR LOCAL REQUIREMENTS



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