Isosorbide Dinitrate belongs to a group of medicines called nitrate vasodilators. These work by relaxing the blood vessels of the heart, reducing the strain on the heart making it easier to pump blood. Isosorbide Dinitrate tablets may be used to:

·       Relieve the pain and frequency of angina attacks.

·       Help control certain types of heart failure.

Do not take Isosorbide Dinitrate Qomel Tablets:

-        are allergic to isosorbide dinitrate, other nitrates or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash, itching or difficulty breathing

-        suffer from anemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)

-        have had a heart attack (myocardial infarction)

-        have had a brain hemorrhage (bleeding)

-        have had a head injury (trauma)

-        have a low blood volume (hypovolemia)

-        have very low blood pressure

-        your blood has stopped circulating around your body properly (circulatory failure)

-        you take sildenafil or any other phosphodiesterase inhibitor

-        you take products that contain Riociguat.

If any of the above applies to you speak to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor before taking Isosorbide Dinitrate Qomel Tablets:

-    if you have an underactive thyroid gland (fatigue, weight gain, constipation, feeling cold, dry skin, hair problems)

-    if you suffer from hypothermia (feeling cold with pale looking skin and low body temperature)

-    if you are malnourished (are undernourished)

-    if you suffer from increased pressure in the eye(s) (glaucoma)

-    if you have severe liver or kidney problems

-    if you have a tendency to feel dizzy or faint on standing up quickly

-    if you have been taking nitrate or nitrite medicines similar to Isosorbide Dinitrate Tablets.

-    suffer from very poor circulation

-    have been diagnosed with any of the following heart conditions:

-    hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with raised intra-cranial (head) pressure.

-    have an abnormally low level of oxygen in the blood and impaired gas exchange due to lung disease or ischemic heart disease.

Other medicines and Isosorbide Dinitrate Qomel Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially:

-    Medicines to treat high blood pressure (e.g. betablockers, calcium channel blockers, vasodilators, ACE inhibitors, monoamine oxidase inhibitors)

-    Alcohol or medicines containing alcohol

-    Tricyclic antidepressants – to treat depression

-    Neuroleptics – to treat psychiatric illnesses and severe anxiety

-    Riociguat – used to treat pulmonary hypertension

-    Sildenafil, or other phosphodiesterase inhibitors, used to treat male erection dysfunction, should not be taken if taking nitrate preparations such as Isosorbide Dinitrate tablets because a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal

-    Ergotamine – used for migraine

-    Sapropterin – used for phenylketonuria (PKU).

Isosorbide Dinitrate Qomel Tablets with alcohol

Drinking alcohol or taking medicines which contain alcohol while taking these tablets may cause these tablets to lower your blood pressure too much, or you may find that alcohol has more effect than usual.

Pregnancy, breast-feeding and fertility.

If you are pregnant, trying to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking Isosorbide Dinitrate Qomel Tablets.

Driving and using machines

Isosorbide Dinitrate Qomel Tablets may cause headache, tiredness and dizziness, especially when you first start taking them. If any of these occur do not drive, use machinery, or perform any tasks that may require you to be alert.

Isosorbide Dinitrate Qomel Tablets contains lactose and sucrose

This medicine contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take Isosorbide Dinitrate Qomel Tablets exactly as your doctor has told you

Important: Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist

Remember: You should not chew the tablets, swallow them whole with a glass of water

The usual doses are

Adults

• Angina: 30-120mg daily in divided doses
• Heart failure: 40-160mg daily in divided doses

Your doctor may also be treating you with other drugs

The maximum daily dose is 240mg in divided doses

Elderly

• A lower dose may be given particularly if you have kidney or liver disease

Children

This medicine is not suitable for children

If you take more Isosorbide Dinitrate Qomel Tablets than you should

Do not take more Isosorbide Dinitrate Qomel Tablets than you should. If you accidentally take too much, immediately contact the nearest hospital casualty department or your doctor

Too many Isosorbide Dinitrate Qomel Tablets may cause your blood pressure to fall too low, making you feel sick, faint and dizzy. A very large overdose could cause a coma or collapse and require immediate resuscitation

If you forget to take Isosorbide Dinitrate Qomel Tablets

Do not take a double dose to make up for a missed dose. Take your next dose at the usual time.

If you stop taking Isosorbide Dinitrate Qomel Tablets

Do not stop taking Isosorbide Dinitrate Qomel Tablets without first talking to your doctor. You should keep taking your medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the tablets your condition may get worse.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist

Like all medicines Isosorbide Dinitrate Qomel can cause side effects, although not everybody gets them

Seek immediate medical help if you have any of the following symptoms:

• Swelling of the face or throat, causing difficulty in breathing or wheezing Fainting or collapse
• Swelling or blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)

Very common side effects (affects more than 1 in 10 people)

• Mild headaches at the start of treatment. Usually, they disappear after a few days

Common side effects (affects less than 1 in 10 people)

• Dizziness
• Tiredness
• Feeling weak
• Fast heartbeat

They may occur for the first few days of treatment or after your dosage has been increased

Uncommon side effects (affects less than 1 in100 people)

• Feeling sick or being sick
• Skin rashes or flushing
• Looking pale
• Excessive sweating
• Restlessness
• Worse angina

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

• Heartburn
• Red or scaly skin (Exfoliative Dermatitis)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet

Keep this medicine out of sight and reach of children.

Do not take after the expiry date which is stated on the label and on the carton after EXP. The expiry date refers to the last day of that month.

Store below 25°C. 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.