NitroMak Retard 2.5 mg 60 capsules

NitroMak Retard 2.5 mg 60 capsules

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.