Nitro Mak Retard 2.5 mg 60 capsules
October Pharma
October Pharma
Composition
Each capsule contains
Nitroglycerin (as Diluted Nitroglycerin) in sustained-release pellets equivalent to 2.5 mg Nitroglycerin.
Inactive ingredients
Hard gelatin capsule, sustained-release pellets (full excipient list not specified), lactose.
Description
Nitromak Retard 2.5 mg is a sustained-release formulation of nitroglycerin designed for the prophylaxis of angina pectoris.
The prolonged-release pellets ensure gradual and long-lasting vasodilatory action, helping reduce the frequency and severity of anginal attacks.
Indications for Use
- Prophylaxis of angina pectoris
(Not intended for treatment of acute anginal attacks).
Dosage and Method of Administration
Adults and elderly
- Dosage is individualized.
- Usually 1-2 capsules, taken two or three times daily.
Method of administration
- For oral use only.
- Swallow whole; do not chew.
- Take between meals.
- Not for sublingual use.
Children
- Not recommended.
Contraindications
- Marked anaemia
- Head trauma
- Cerebral haemorrhage
- Incipient glaucoma
- Concomitant use with sildenafil or other PDE-5 inhibitors
- Hypersensitivity to nitroglycerin or other nitrates.
Precautions
- Contains lactose: contraindicated in lactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
- Abrupt discontinuation may worsen angina; taper gradually.
- May potentiate the effects of peripheral vasodilators.
- Sildenafil significantly enhances nitrate-induced hypotension - strict contraindication.
Side Effects
Common
- Headache
- Facial flushing
Toxic effects in overdose
- Vomiting
- Restlessness
- Cyanosis
- Methaemoglobinaemia
- Syncope.
Pregnancy and Breastfeeding
There is no established safety data.
Nitrates should not be used during pregnancy or lactation, unless considered essential by the physician.
Storage
Store at temperatures not exceeding 30°C.
Keep in a dry place.
Protect from moisture.
Keep out of reach of children.
Packaging
Carton box containing 6 blisters.
Each blister contains 10 sustained-release hard gelatin capsules.
Includes an inner leaflet.