Nitrocontin 2.6## (strength format, wrong smpc)

Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin sublingual tablets are a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. ( 1 )

• Administer one tablet under the tongue or in the buccal pouch at the first sign of an acute anginal attack
• Allow tablet to dissolve without swallowing
• One additional tablet may be administered every 5 minutes until relief is obtained
• No more than three tablets are recommended within a 15-minute period
• If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, seek prompt medical attention
• Nitroglycerin sublingual tablets may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack
• For patients with xerostomia, a small sip of water prior to placing the tablet under the tongue may help maintain mucosal hydration and aid dissolution of the tablet
• Administer nitroglycerin sublingual tablets at rest, preferably in the sitting position. • At the onset of an attack, administer one tablet under the tongue or buccal pouch
• One additional tablet may be administered every 5 minutes as needed
• No more than 3 total tablets are recommended within a 15 minute period. • If chest pain persists after three tablets, seek prompt medical attention. • May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack

Nitroglycerin Sublingual Tablets are supplied as white, round, flat-faced tablets in three strengths: 0.3 mg (Coded with “N” on one side and “3” on the other) 0.4 mg (Coded with “N” on one side and “4” on the other) 0.6 mg (Coded with “N” on one side and “6” on the other) Sublingual tablets, 0.3 mg; 0.4 mg; 0.6 mg ( 3 )

• The safety and effectiveness of nitroglycerin
• In pediatric patients have not been established

Clinical studies of nitroglycerin sublingual tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• GREENSTONE ® BRAND Distributed by: Greenstone LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc
• GST:NITR:R1 Revised: 10/2024

• Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. ( 4.1 , 7.1 ) • Severe anemia ( 4.2 ) • Increased intracranial pressure ( 4.3 ) • Hypersensitivity to nitroglycerin or to other nitrates or nitrites or any excipient ( 4.4 ) • Circulatory failure and shock ( 4.5 ) 4.1 PDE-5-Inhibitors and sGC-Stimulators Do not use nitroglycerin sublingual tablets in patients who are taking PDE-5 Inhibitors …

Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. ( 7.2 ) 7.1 PDE-5-Inhibitors and sGC-Stimulators Nitroglycerin sublingual tablets are contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). PDE-5-Inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. Nitroglycerin sublingual tablets are contraindicated in patients who are taking soluble guanylate cyclase (sGC) stimulators. Concomitant use can cause hypotension. …

• Tolerance: Excessive use may lead to tolerance. ( 5.1 ) • Hypotension: Severe hypotension may occur. ( 5.2 ) 5.1 Tolerance Excessive use may lead to the development of tolerance. Only the smallest dose required for effective relief of the acute angina attack should be used. A decrease in therapeutic effect of sublingual nitroglycerin may result from use of long-acting nitrates. 5.2 Hypotension Severe hypotension, particularly with upright posture, may occur with small doses of nitroglycerin particularly in patients with constrictive pericarditis, aortic or mitral stenosis, patients who may be volume-depleted, or are already hypotensive. …

The following adverse reactions are discussed in more detail elsewhere in the label: • Hypotension [see Warnings and Precautions (5.2) ] • Headache [see Warnings and Precautions (5.4) ] • Hypersensitivity [see Contraindications (4.4) ] Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses. Syncope due to nitrate vasodilatation has been reported. …

8.1 Pregnancy Risk Summary Limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk of major birth defects or miscarriage. In animal reproduction studies, there were no adverse developmental effects when nitroglycerin was administered intravenously to rabbits or intraperitoneally to rats during organogenesis at doses greater than 64-times the human dose [see Data ] . …

10.1 Signs and Symptoms, Methemoglobinemia Nitrate overdosage may result in: severe hypotension, persistent throbbing headache, vertigo, palpitation, visual disturbance, flushing and perspiring skin (later becoming cold and cyanotic), nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis and anorexia, initial hyperpnea, dyspnea and slow breathing, slow pulse (dicrotic and intermittent), heart block, increased intracranial pressure with cerebral symptoms of confusion and moderate fever, paralysis and coma …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.