COVONIA DRY COUGH SUGAR FREE FORMULA - patient leaflet, side effects, dosage

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Proof Number: 5 __________ Date: 23.04.2021

Operator: Artwork Number: 1210365

CRN: 16473 / MOC-2021–0136 Suffix: A

Local Authority submission required: Yes

Approved by:

Date:

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STADA

Product Title:

Covonia Dry Cough Sugar Free Formula

Pack Size: 150ml

M at.N o:92789652004­_150ML_LBA

Dimensions: 73 × 90mm

Keyline Ref:

Barcode: 5011309432619 V­erified

Pharmacode:

Datamatrix: 2789652004 Ve­rified

Reason for Change:

Move to synthetic back label, safety updates for opioids and excipient guideline updated

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Covonia Dry Cough Sugar Free Formula is an oral liquid for the symptomatic relief of dry or irritating coughs.

SHAKE THE BOTTLE. Take the solution by mouth.

Adults, the elderly and children over 12 years:

Take one or two 5mI spoonfuls, three or four times a day. Do not give more than 4 doses in 24 hours.

Warning: Do not take more medicine than the label tells you to.

Do not give to children under 12 unless your doctor tells you to.

Do not take with other cough and cold medicines.

If symptoms persist consult your doctor.

Keep out of the sight and reach of children.

Peel where shown for further precautions.

Active ingredient per 5ml: pholcodine monohydrate 5mg.

Also contains amongst other ingredients: sodium parahydroxyben­zoates (E215, E217, E219,), propylene glycol (E1520).

See reverse for full list.

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This product contains pholcodine P1

monohydrate, which reduces the desire to cough. It relieves dry coughs which are without phlegm.

• An allergy to any of the ingredients listed in section 3.

«Liver disease«Shallow breath or breathing difficulties«Chest problems or chest infections for a long time«An asthma attack.

«Taken MAOI’s (monoamine oxidase inhibitors) for depression within the last two weeks.

• Ever developed a severe skin rash or skin that peels, blisters and/or sores in the mouth after taking this medicine or other related medicines.

■Talk to your doctor if you oryourchild have…

• Kidney problems Liver problems.
• A history of asthma or other breathing problems including bronchitis.
• A cough for a long time or a cough which produces lots of phlegm. A history of drug abuse; pholcodine is an opioid and addiction is observed with opioids as a class. Serious skin reactions, including acute generalized exanthematous pustulosis (AGEP), have been reported with the use of this medicine. AGEP is a generalized, red, scaly rash with bumps under the skin and vesicles associated with fever. Most common location: mainly located on the folds of the skin, the trunk and the upper limbs. The highest risk of serious skin reactions occurrence is especially during the first week of treatment. If you develop a severe rash or any of these skin symptoms, stop taking this medicine and contact or see a doctor immediately.

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92789652004

P3

/ ■ Driving and using machines…

✓ This medicine may cause drowsiness. If you are affected do not drive or operate machinery.

■ Important ingredient information

This medicine contains:

• sodium parahydroxyben­zoates which may cause allergic reactions (possibly delayed).
• 52.3mg propylene glycol in each 5ml dose.
• less than 1 mmol sodium (23mg) per 5ml dose, that is to say essentially ‘sodium-free’.

92789652004

■Talk to your doctor or pharmacist if you or your child P2 are taking…

• Medicine for high blood pressure, e.g. ACE inhibitors, beta blockers.
• Diuretics, which help remove water from the body, e.g. furosemide, hydrochlorothi­azide.
• Medicines used to treat sleeplessness, anxiety and schizophrenia.
• Alcohol or tranquillisers.
• Pain killers, e.g. morphine.
• Or are having surgery, as muscle relaxants used may react with this medicine.

Concomitant use of this product and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breaming (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe this product together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

• ■ Pregnant or breastfeeding…

Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding. This medicine should not be used unless the doctor has told you to do so.

If you use it when breastfeeding, pholcodine monohydrate in this medicine will be present in small amounts in your milk.

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Reporting of side effects \

If you get any side effects, talk to your doctor, pharmacist \ or nurse. This includes any possible side effects not listed in > this leaflet. You can also report side effects directly via the Yellow Card Scheme at: "4 or search for ‚MHRA Yellow Card‘ in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• 3. Further information

• ■ If you accidentally take too much see a doctor straight away. Take the pack with you to show which medicine you have swallowed.

• Do not use after the expiry date. The expiry date refers to the last day of that month.
• Return any unused medicine to the pharmacy for disposal.

Print layout diagram

90mm X 73mm 3Ply Multipeel with Alternating Inset Corner Opening