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Ventmax Sr 4mg

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567 FR00265 V6 VENTMAX 567 FR00265 V6 15/06/15 17:46 Pagel

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ventmax® SR 4 mg & 8 mg Capsules

salbutamol

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 Ventmax is and what it is used for

2.    What you need to know before you take Ventmax

3.    How to take Ventmax

4.    Possible side effects

5.    How to store Ventmax

6.    Contents of the pack and other information.

1. What Ventmax is and what it is used for


Ventmax SR Capsules are used to help relieve the symptoms of asthma and other conditions that cause breathing problems. The active ingredient, salbutamol, is one of a group of medicines called bronchodilators or ‘relievers’. Salbutamol relaxes the muscles in the walls of the small air passages in the lungs. This helps to open up the airways and so helps to relieve chest tightness, wheezing and cough so that you can breathe more easily.

The capsules are manufactured in a way that allows the salbutamol to be released and slowly absorbed by your body so that you get relief over a period of several hours.

Taking Ventmax at the same time as other prescribed anti-inflammatory medicines, such as steroids, will help you to breathe more easily.

2. What you need to know before you take Ventmax

Do not take Ventmax:

•    if you are allergic to salbutamol or any of the other ingredients contained in Ventmax.

Take special care with Ventmax and always tell your doctor if:

•    you suffer from an over active thyroid gland

•    you suffer from high blood pressure

•    you suffer from any disease of the heart or if your symptoms appear to be getting worse

•    you experience chest pains

•    you suffer from any disease of the heart

•    you suffer from an irregular heart beat

•    you are diabetic

•    you suffer from low levels of potassium in your blood

•    your asthma seems to be getting worse. Perhaps you are more wheezy and short of breath than usual, your capsules or ‘reliever' inhaler seems to be less effective, you require more capsules or more puffs from your ‘reliever' inhaler than usual, or you do not seem to be getting better. Your doctor may reassess your asthma and may change your treatment or give you an extra medicine.

If you experience breathing difficulties while taking Ventmax, you may need to use a quick-acting ‘reliever’ inhaler to help relieve your symptoms.

If you are an athlete it is important that you know that the salbutamol in these capsules may produce a positive dope test reaction.

Taking other medicines

Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Remember to take these medicines and your inhalers with you if you have to go into hospital.

In particular, tell your doctor if you are taking:

•    beta-blockers (such as propanolol) or water tablets (diuretics), used to treat high blood pressure or a heart condition

•    theophylline, aminophylline or steroids, used to treat asthma

•    antidepressants, particularly monoamine oxidase inhibitors

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or could become pregnant, talk to your doctor before taking your capsules.

Important information about some of the ingredients of Ventmax

Ventmax contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Please read the back of this leaflet

3.    How to take Ventmax

Always take your capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The label on the carton will tell you how many capsules you should take and when. It is very important that you take your capsules regularly. Do not stop treatment even if you feel better unless told to do so by your doctor.

While you are taking Ventmax your doctor will want to check your asthma regularly by carrying out simple breathing tests and may need to carry out blood tests from time to time (see also: Section 4 - Possible side effects).

Dosage

Ventmax is formulated so that you only have to take your capsules twice a day.

It is important that you take your capsules 12 hours apart, preferably one in the morning when you get up and one in the evening. Your capsules must be swallowed whole with a glass of water while you are sitting or standing. Do not break or chew your capsules.

For Adults, the elderly and children over the age of 12 years

The usual dose is one 8 mg capsule twice a day.

For Children aged 3 to 12 years

The usual dose is one 4 mg capsule twice a day.

If you take more Ventmax than you should

If you take more Ventmax than you should, contact your nearest casualty department or tell your doctor or pharmacist immediately. If you take too much Ventmax it will cause your heart to beat faster than normal, affect your blood pressure and make you feel shaky, nervous and mentally calm or peaceful.

If you forget to take Ventmax

If you forget to take Ventmax, take it as soon as you remember. If it is almost time for your next dose, wait until this dose is due. 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, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, Ventmax can cause side effects, although not everybody gets them.

Very rare allergic reactions, including nettle rash or hives, wheezing, fall in blood pressure, collapse or painless swelling of the skin on the face, neck, hands, feet and lips have been reported. If you experience any of these, contact your doctor or casualty department immediately.

Abnormally low levels of potassium in the blood (hypokalaemia) can be caused by the regular taking of salbutamol, such as Ventmax. The low levels of potassium, which can cause you to feel weak and thirsty, can worsen during an acute asthma attack. Therefore, while you are taking Ventmax your doctor may need to carry out blood tests from time to time.

The following side effects have been also reported. Tell your doctor as soon as possible if you suffer from any of these side effects but do not stop treatment unless told to do so:

Uncommon (affects less than 1 in 100 people) • feeling your heartbeat

Rare (affects less than 1 in 1,000 people)

•    hyperactivity in children

•    rapid heartbeats with or without flushing may occur at high dose

•    increased blood flow to your extremities

Very rare (affects less than 1 in 10,000 people)

•    irregular heartbeat or an extra beat of the heart

•    muscle cramps

Unknown

• feeling nervous    • nausea

• headache    • vomiting

•    dizziness

•    restriction of blood flow to the heart

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 YellowCard 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 Ventmax

•    Keep this medicine out of the sight and reach of children.

•    Do not use Ventmax after the expiry date which is stated on the blister and carton. 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 dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ventmax contains:

The active substance in your capsules is salbutamol. Each capsule contains 4 mg or 8 mg of salbutamol.

The other ingredients are sucrose, maize starch, colloidal anhydrous silica, methacrylic copolymer, ethylcellulose, dibutyl sebacate, talc, gelatin, titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172), erythrosine (E127), patent blue V (E131), shellac, isopropyl alcohol, n-butyl alcohol, propylene glycol, water, ammonium hydroxide, potassium hydroxide.

What Ventmax looks like and the contents of the pack:

Ventmax SR 4 mg capsules are opaque grey and pate green, marked ‘4 mg’. Ventmax SR 8 mg capsules are opaque white, marked‘8 mg’. They are packed in blister packs of 28, 30, 56 and 60 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

The Marketing Authorisation Holder and manufacturer of Ventmax is Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK.

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.

This leaflet was last revised in 07/2015    FR00265.V6 / CP0009/5