ATROPINE ACCORD 0.1 mg/mL Injectable Solution in Pre-filled Syringe

2. What you need to know before you use Atropine Accord

Do not use Atropine Accord:

• if you are allergic (hypersensitive) to atropine or any of the other ingredients of this medicine (listed in section 6);
• if you have urinary problems;
• if you have high pressure in the eye (glaucoma);
• if you suffer from esophageal disease (esophageal achalasia), intestinal blockage (paralytic ileus) or an acute form of colonic distension (toxic megacolon).

These contraindications do not apply in cases of potentially life-threatening emergencies.

Warnings and precautions

Consult your doctor before starting to use Atropine Accord if you suffer from:

• hyperthyroidism;
• prostate disease;
• heart failure;
• liver or kidney disease;
• certain heart diseases;
• stomach disease, such as pyloric stenosis;
• chronic bronchitis;
• fever;
• if you are a child or an elderly person;
• severe myasthenia (severe muscle weakness);
• heartburn (reflux).

Other medicines and Atropine Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:

• tricyclic antidepressants;
• certain antihistamines;
• medicines for Parkinson's disease;
• phenothiazine, clozapine or neuroleptic drugs (for mental illnesses);
• quinidine or disopyramide (for heart diseases);
• antispasmodics (for irritable bowel syndrome).

Pregnancy and breast-feeding

Pregnancy

Limited data on the use of atropine in pregnant women indicate that there are no adverse effects on pregnancy or fetal health. Atropine crosses the placenta. Intravenous administration of atropine during pregnancy or at term may cause a faster heart rate in the fetus and mother. This medicine should only be administered during pregnancy after careful consideration of the benefits and risks of treatment.

Breast-feeding

Small amounts of atropine may pass into breast milk and have effects on the breast-fed child. Atropine may inhibit milk production. Your doctor will weigh the benefit of breast-feeding against the benefit of treatment. If treatment is decided, breast-feeding should be interrupted. However, if breast-feeding is continued during treatment, your doctor will perform additional tests on the child.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

The injection of atropine can cause confusion or blurred vision. You should not drive or operate machinery after receiving an injection.

Atropine Accord contains sodium

Each 5 ml syringe contains less than 23 mg of sodium (1 mmol) per pre-filled syringe, i.e. essentially "sodium-free".

Each 10 ml syringe contains 35.4 mg of sodium (main component of table/cooking salt) in each pre-filled syringe. This is equivalent to 1.77% of the maximum recommended daily intake of sodium for an adult.

3. How to use Atropine Accord

Your doctor will decide the correct dose for you and how and when the injection will be administered. In case of doubt, consult your doctor again.

The usual dose is:

As pre-medication before anesthesia

Intravenous (IV) administration immediately before surgery; if necessary, intramuscular administration 30-60 minutes before the operation is possible.

Adults: 0.3-0.6 mg IV

Children: 0.01-0.02 mg/kg, adjusting the dose according to the patient's response and tolerance (maximum 0.6 mg per dose).

To counteract the effects of muscle relaxants:

Adults: 0.6-1.2 mg IV with neostigmine.

Children: 0.02 mg/kg IV

In case of low heart rate, heart block or cardiac arrest:

Adults:

• Sinus bradycardia (low pulse rate): 0.5 mg IV, every 2-5 minutes until the desired heart rate is achieved.
• AV block (blockage of the transmission of contraction between the atrium and ventricle): 0.5 mg IV, every 3-5 minutes (maximum 3 mg).

Children:

0.02 mg/kg IV in a single dose (maximum dose 0.6 mg).

As an antidote for organophosphate poisoning (insecticides or nerve gas), anticholinesterases or poisoning by muscarinic mushrooms:

Adults: 0.5-2 mg IV, may be repeated after 5 minutes and then every 10-15 minutes as needed.

Children: 0.02 mg/kg, may be repeated several times until the signs and symptoms disappear.

It may be that other forms of this medicine are more suitable if a dose higher than 0.5 mg is needed.

Use in children

Atropine is used to treat children from birth with a weight over 3 kg.

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

This injection will be administered by a doctor or nurse, so it is unlikely that you will receive too much atropine. If you think you have been given too much atropine, feel that your heart is beating very fast, breathe rapidly, have a high fever, feel restless, confused, have hallucinations or lose coordination, you should inform the person who administered the injection.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects depend on the dose you receive and usually disappear when treatment is stopped.

Rarely, an allergic reaction may occur. This can cause skin rash, intense itching, skin peeling, swelling of the face (especially around the lips and eyes), tightness in the throat and difficulty breathing or swallowing, fever, dehydration, shock and fainting. All these are very serious side effects. Tell your doctor immediately if you experience any of these side effects. You may need urgent medical attention.

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

• visual disturbances (dilated pupils, difficulty focusing, blurred vision, light intolerance);
• reduced bronchial secretion;
• dry mouth (difficulty swallowing and speaking, feeling of thirst);
• constipation and heartburn (reflux);
• reduced gastric acid secretion;
• loss of taste;
• nausea;
• vomiting;
• feeling of bloating;
• absence of sweating;
• dry skin;
• hives;
• rash.

Common side effects (may affect up to 1 in 10 people)

• excitement (especially with higher doses);
• loss of coordination (especially with higher doses);
• confusion (especially with higher doses);
• hallucinations (especially with higher doses),
• excessive temperature;
• certain heart disorders (fast heart rate, irregular heart rate, temporary slowing of the heart rate);
• flushing;
• difficulty urinating.

Uncommon side effects (may affect up to 1 in 100 people)

• psychotic reactions.

Rare side effects (may affect up to 1 in 1,000 people)

• allergic reactions;
• epileptic seizures (convulsions);
• drowsiness.

Very rare side effects (may affect up to 1 in 10,000 people)

• severe allergic reaction;
• irregular heart rate, including ventricular fibrillation;
• chest pain;
• peak in blood pressure.

Frequency not known (cannot be estimated from the available data)

• headache;
• restlessness;
• unstable gait and balance problems;
• insomnia.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atropine Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, syringe and blister. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atropine Accord

The active substance is Atropine Sulfate: Each ml of solution for injection contains 0.1 mg of atropine sulfate monohydrate, which is equivalent to 0.083 mg of atropine.

Each 5 ml syringe contains 0.5 mg of atropine sulfate monohydrate, which is equivalent to 0.415 mg of atropine.

Each 10 ml syringe contains 1 mg of atropine sulfate monohydrate, which is equivalent to 0.83 mg of atropine.

The other ingredients are: Sodium chloride, concentrated hydrochloric acid (for pH adjustment), water for injections.

Appearance of the product and pack contents.

This medicine is a clear and colorless solution free of visible particles in a pre-filled syringe.

Pre-filled glass syringe (type I transparent glass) of 5 ml with plug, plunger stopper (bromobutyl rubber) and plunger rod (polypropylene). There are graduations of 0.5 mL on the syringe body, from 0 mL to 5 mL.

Pre-filled glass syringe (type I transparent glass) of 10 ml with plug, plunger stopper (bromobutyl rubber) and plunger rod (polypropylene). There are graduations of 1 mL on the syringe body, from 0 mL to 10 mL.

The pre-filled syringe is supplied without a needle, packaged in an outer carton.

Atropine Accord is supplied in cartons of 1 pre-filled syringe.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6ª planta

08039 Barcelona.

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice,

Poland

or

Pharmadox Healthcare Ltd.

KW20A

Kordin Industrial Park,

Paola, PLA3000, Malta

or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040,

Spain

Date of last revision of this leaflet: September 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS). http//www.aemps.gob.es

--------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

The pre-filled syringe is intended for use in a single patient. Discard the syringe after use. Do not reuse.

The product should be visually inspected for particles and discoloration before administration. Only the clear, colorless solution free of particles and precipitates should be used.

The needle size required for use with the syringe is 23-20 gauge for IV administration and 23-21 gauge for IM administration.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.