Atropine sulfate Noridem

Package leaflet: Information for the patient

Atropina solfato Noridem 1 mg/mL injection solution

Atropine sulfate
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Atropina solfato Noridem is and what it is used for
2. What you need to know before using Atropina solfato Noridem
3. How to use Atropina solfato Noridem
4. Possible side effects
5. How to store Atropina solfato Noridem
6. Contents of the pack and other information

1. What Atropina solfato Noridem is and what it is used for

Atropina solfato Noridem is used in children of all ages and in adults for the treatment of:

• Bradycardia induced by anaesthetics or other drugs.
• In combination with neostigmine during reversal of the effect of non-depolarizing muscle relaxants.
• Poisoning by organophosphate pesticides and other anticholinesterase agents.

Atropina solfato Noridem may also be used as a pre-anaesthetic before induction of general anaesthesia (reduces the risk of vagal inhibition and decreases salivary and bronchial secretions).

2. What you need to know before using Atropine sulfate Noridem

Do not use Atropine sulfate Noridem

• if you are allergic to atropine or any of the other ingredients of this medicine (listed in section 6).
• in case of prostatic hypertrophy, as it may promote urinary retention
• in case of gastrointestinal tract obstruction (e.g. pyloroduodenal stenosis)
• in case of paralytic ileus or intestinal atony (especially in elderly and debilitated patients)
• in case of ulcerative colitis, as it may cause ileus or megacolon
• in case of Myasthenia gravis (unless administered to reduce muscarinic adverse effects caused by anticholinesterase agents)
• in case of closed-angle or narrow-angle glaucoma (between the iris and cornea), as it may increase intraocular pressure
• when the ambient temperature is high, especially in children and in cases of hyperthermia
• in case of heart failure, cardiac surgery, or tachycardia, as it may further increase heart rate
• in case of acute hemorrhage associated with unstable cardiovascular function
• in case of thyrotoxicosis

These contraindications do not apply in life-threatening emergency situations such as
bradycardia or organophosphate pesticide poisoning.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Atropine sulfate Noridem.

• Atropine must be administered with caution in children and elderly patients, as they may be more susceptible to adverse effects. The same caution should be exercised in cases of pseudomembranous colitis, diarrhea, hyperthyroidism, gastrointestinal infection (e.g. dysentery), liver or kidney disease, and hypertension.
• Systemic administration of antimuscarinic agents in debilitated patients with chronic lung disease may lead to the formation of bronchial mucus plugs due to reduced bronchial secretions.
• In the treatment of parkinsonism, dose increases and treatment modifications should be gradual (antimuscarinic treatment must not be abruptly discontinued).
• Patients with Down's syndrome appear to have increased sensitivity to atropine. Conversely, patients with albinism show some resistance to this drug.
• Administration of small doses may lead to paroxysmal bradycardia.
• Since antimuscarinics may delay gastric emptying, they may cause stasis in patients with gastric ulcers. Precautions are also required in patients with gastroesophageal reflux or hiatal hernia associated with gastroesophageal reflux, as antimuscarinics reduce gastric motility and lower esophageal sphincter pressure.
• Regarding laboratory test results, antimuscarinics interfere with gastric acid secretion tests. Administration of antimuscarinics is not recommended within 24 hours prior to such tests, as these drugs antagonize the effects of pentagastrin and histamine on the assessment of gastric acid secretion function. Antimuscarinics, and particularly atropine, interfere with the excretion of phenolsulfonphthalein (PSP). Atropine uses the same tubular secretion mechanism as phenolsulfonphthalein (PSP), leading to reduced urinary excretion of PSP. Patients undergoing this test should not receive atropine simultaneously.
• Since antimuscarinics may increase intraocular pressure, monitoring of this parameter is advisable in certain patients depending on their condition.

Other medicines and Atropine sulfate Noridem
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
a) Drugs with anticholinergic properties
Patients receiving antimuscarinic agents together with amantadine, antihistamines, anti-Parkinson drugs,
butyrophenones or phenothiazines, tricyclic antidepressants, or antiarrhythmic drugs with anticholinergic properties (e.g. procainamide) have an increased risk of developing anticholinergic adverse effects.
b) Effects on gastrointestinal absorption of drugs
Reduced gastric motility caused by antimuscarinic agents may affect the absorption of certain drugs. For example, concomitant administration of an antimuscarinic agent and levodopa may reduce levodopa absorption in the intestine, as it increases drug metabolism in the stomach. If antimuscarinic treatment is discontinued without simultaneously reducing the levodopa dose, toxic effects due to increased levodopa absorption may occur.
Patients taking antimuscarinics and digoxin concurrently should be monitored, as they may develop digitalis toxicity.
Since antimuscarinics may reduce gastric hydrochloric acid production and/or increase gastric pH, they may decrease gastrointestinal absorption of ketoconazole. If concomitant therapy is necessary, the antimuscarinic agent should be administered at least two hours after ketoconazole.
Potentially, antimuscarinics may delay the therapeutic effect (e.g. analgesia, antipyretic action) of acetaminophen.
c) Glucocorticoids, corticotropin (ACTH), or haloperidol
Long-term concomitant antimuscarinic therapy may lead to increased intraocular pressure. Additionally, the antipsychotic efficacy of haloperidol may be reduced in schizophrenic patients.
d) Urinary alkalinizing agents (antacids containing calcium and/or magnesium, carbonic anhydrase inhibitors,
citrates, and sodium bicarbonate)
Urinary excretion of antimuscarinics may be delayed due to urine alkalinization, thereby enhancing therapeutic and/or adverse effects of these drugs.
e) Cyclopropane
Concomitant intravenous administration of antimuscarinics with the anesthetic cyclopropane may cause ventricular arrhythmias.
f) Guanadrel, guanethidine
Concomitant administration may antagonize the inhibitory antimuscarinic action on gastric hydrochloric acid secretion.
g) Monoamine oxidase inhibitors (MAO), including furazolidone, procarbazine, and pargyline
Concomitant administration may increase muscarinic adverse effects due to the secondary antimuscarinic action of these drugs. Moreover, MAO inhibitors may block antimuscarinic detoxification, thereby enhancing their action.
h) Opioid analgesics
Concomitant administration with antimuscarinics may increase the risk of severe constipation, which may lead to paralytic ileus and/or urinary retention.
i) Potassium chloride, especially wax-matrix formulations
Concomitant administration with antimuscarinics may increase the severity of gastrointestinal disturbances induced by potassium chloride.
Atropine sulfate is compatible with butorphanol tartrate and buprenorphine hydrochloride. It is incompatible with bromides, iodides, and bases (e.g. sodium bicarbonate, alkaline barbiturates), bitartrate norepinephrine, and bitartrate metaraminol.
Atropine sulfate may be administered concurrently with thiopental sodium provided that it is administered before thiopental.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Atropine crosses the placenta.
Intravenous administration of atropine during pregnancy may cause fetal tachycardia. Therefore, atropine should be administered during pregnancy only when potential benefits justify the possible risks to the fetus.
Breastfeeding
No human problems have been reported regarding atropine administration during breastfeeding. However, the risk–benefit ratio should be considered, as traces of atropine have been found in breast milk and infants are particularly sensitive to these drugs.
Antimuscarinics inhibit milk production.
Fertility
Atropine sulfate has reduced fertility in male rats, likely due to its inhibitory effect on sperm and semen transport during ejaculation.
Although well-controlled studies in humans have not been conducted, animal studies do not indicate direct or indirect harmful effects regarding reproductive toxicity.
Driving and using machines
Since antimuscarinics may cause drowsiness and blurred vision, patients receiving these drugs should not perform activities requiring mental alertness or visual acuity (e.g. operating machinery).
Atropine sulfate Noridem contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per mL, i.e. essentially 'sodium-free'.

3. How to use Atropina solfato Noridem

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults

• Treatment of bradycardia: administer 0.5 mg intravenously; if necessary, repeat the dose every 3–5 minutes, up to a total of 3 mg.
• In combination with neostigmine during reversal of the effect of non-depolarizing muscle relaxants: administer 0.6–1.2 mg by intravenous injection.
• Premedication (to reduce the risk of vagal inhibition and salivary and bronchial secretions): administer 0.3–0.6 mg by intravenous injection immediately before induction of anaesthesia, or by intramuscular/subcutaneous injection 30–60 minutes before induction.
• As an antidote (treatment of anticholinesterase poisoning, e.g. organophosphate pesticides, and treatment of mushroom poisoning): administer 0.5–2 mg of atropine sulfate intravenously. The dose may be repeated after 5 minutes and subsequently every 10–15 minutes as needed, until signs and symptoms disappear (this dose may be exceeded several times).

Paediatric population

• Treatment of bradycardia: administer 0.02 mg/kg body weight as a single intravenous dose, up to a maximum of 0.6 mg.
• In combination with neostigmine during reversal of the effect of non-depolarizing muscle relaxants: 0.02 mg/kg body weight by intravenous injection.
• Premedication (to reduce the risk of vagal inhibition and salivary and bronchial secretions): administer 0.01–0.02 mg/kg body weight (maximum 0.6 mg per dose) by intravenous injection immediately before induction of anaesthesia or by intramuscular/subcutaneous injection 30–60 minutes before induction.
• As an antidote (treatment of anticholinesterase poisoning, such as organophosphate pesticides, and treatment of mushroom poisoning): administer 0.05 mg/kg body weight intravenously, repeated several times until disappearance of muscarinic intoxication signs and symptoms.

If you use more Atropina solfato Noridem than you should
Atropine poisoning occurs when the patient receives excessive doses. It should be borne in mind that sensitivity to atropine varies from person to person.
Administration of toxic doses of this medicine causes tachycardia, rapid breathing, hyperthermia, and stimulation of the central nervous system. This leads to anxiety, confusion, excitement, psychotic reactions, hallucinations, and delirium. Seizures may occasionally occur. Facial and upper chest skin rash may also appear. In severe poisoning, central stimulation may progress to central nervous system depression, coma, respiratory or circulatory failure, and death.
To counteract anticholinergic symptoms, cholinergic drugs such as neostigmine may be administered (1 mg of neostigmine intramuscularly every 2–3 hours). The greatest danger lies in the central effects of this drug, which are not antagonized by parasympathomimetic agents and can only be treated symptomatically. Therefore, if agitation is present, suppressive drugs such as diazepam are used; if the depressive phase has been reached, caffeine may also be administered. When blood pressure drops excessively, vasoactive amines may be administered. In case of severe respiratory depression, artificial ventilation with oxygen administration must be implemented.

If you forget to take Atropina solfato Noridem
Your doctor or nurse will have instructions on when to administer the medicine. If you think a dose has been missed, inform your doctor or nurse.
Do not take a double dose to make up for a forgotten dose.

If you stop using Atropina solfato Noridem
In the treatment of parkinsonism, increasing the dose of atropine and modifying the treatment should be done gradually (antimuscarinic treatment must not be stopped abruptly).
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects of atropine are generally common and, in most cases, related to prolonged pharmacological action and dose-dependent.

Very common: may affect more than 1 in 10 people

• Blurred vision
• Dry mouth (xerostomia)

Common: may affect up to 1 in 10 people

• Pupil dilation (mydriasis) with loss of ocular accommodation (cycloplegia), photophobia, glaucoma
• Reduced gastrointestinal tone and motility, constipation, vomiting, paralytic ileus, dysphagia, altered taste
• Dysuria and urinary retention
• Bradycardia (after low-dose administration), tachycardia (after high-dose administration), palpitations, and cardiac arrhythmia
• Skin flushing and dry skin, urticaria, anaphylactic reaction
• Headache, disorientation in time and space, drowsiness
• Hallucinations

Uncommon: may affect up to 1 in 100 people

• Insomnia
• Dizziness
• Nasal congestion
• Impotence
• Hyperthermia

Rare: may affect up to 1 in 1,000 people

• Hypersensitivity

Very rare: may affect up to 1 in 10,000 people

• Anaphylactic reactions, including anaphylactic shock

Not known (frequency cannot be estimated from the available data)

• Leukocytosis

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atropine Sulfate Noridem

Keep this medicine out of the sight and reach of children.
Store below 30°C. Keep the ampoules in the outer packaging to protect the medicine from light.
After first opening: the product must be used immediately. If not used immediately, the user is responsible for the storage conditions and duration of use.
Do not use this medicine after the expiry date stated on the box and on the ampoule. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Atropina solfato Noridem contains

• The active substance is atropine sulfate. Each mL of solution contains 1 mg of atropine sulfate.
• The other components are: sodium chloride, sulfuric acid, and water for injections.

Description of the appearance of Atropina solfato Noridem and package contents
Atropina solfato Noridem 1 mg/mL is a clear, colourless solution supplied in glass vials, each containing 1 mL of injectable solution.
This medicinal product is available in pack sizes of 5, 10, 20, 50 or 100 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Noridem Enterprises Limited
Evagorou & Makariou
Mitsi Building 3, Office 115
1065 Nicosia, Cyprus

Manufacturer:
DEMO S.A. PHARMACEUTICAL INDUSTRY
21st Km National Road Athens–Lamia,
14568 Krioneri, Attiki, Greece
Tel: +30 210 8161802,
Fax: +30 2108161587

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Portugal: Atropina Noridem
France: ATROPINE (SULFATE) NORIDEM 1 mg/mL, solution injectable
Belgium: Atropine sulfate Noridem 1 mg/ml, solution injectable / oplossing voor injectie / Injektionslösung
Luxembourg: ATROPINE (SULFATE) NORIDEM 1 mg/mL, solution injectable
Austria: Atropinsulfat Noridem 1 mg/ml Injektionslösung
Czech Republic: Atropine Noridem
Denmark: Atropine Noridem
Finland: Atropine Noridem 1 mg/ml injektioneste, liuos
Hungary: Atropinum sulfuricum Noridem 1 mg/mL oldatos injekció
Italy: Atropina solfato Noridem
Norway: Atropine Noridem
Poland: Atropinum sulfuricum Noridem
Romania: Sulfat de atropină Noridem 1 mg/mL soluţie injectabilă
Slovakia: Atropine Noridem
Spain: Atropina Noridem 1 mg/mL solución inyectable EFG
Sweden: Atropine Noridem