Patient leaflet - ACECIL 600 MG EFFERVESCENT TABLETS
AceCil 600mg Effervescent Tablets
Acetylcysteine
Read all of this leaflet carefully before you start taking this medicine because it contains important information fur you.
Always taka this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. Ibis includes any possible side effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
What is in this leaflet
1. What AceCil GOOmg Effervescent Tablets is and what it is used for
2. What you need to know before you take AceCil 600mg Effervescent Tablets
3. How to take AceCil GOOmg Effervescent Tablets
4. Possible side effects
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5. Howto store AceCil 600mg Effervescent Tablets
6. Contents of the pack and other informati on
1. what acecil 600mg effervescent tablets is and what it is used for
Acetylcysteine breaks down tough, sticky mucus, so that the liquid is thin and can be easily coughed up. This medicine can be used in respiratory diseases such as bronchitis, emphysema, mucoviscidose and bronchiectasis.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
AcoCil BOOmg Effervescent Tablets is indicated for adults only.
2. what you need to know before you take acecil 600mg effervescent tablets
Do nottake AceCil 600mg Effervescent Tablets
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- if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).
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- if your child isunder2yearsofago.
if you area child or prepantwoman sufferingfrem phenylketonuria.
Warningsand precautions
Talkto yourdoctor or pharmacist beforetakhig AceCil GOOmg Effervescent Tablets
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* Ifyourchildisbetween2and18yearsof age. Otherformsandstrengthsofacetylcysteinearemoresuitableforthesepatientgroups.
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* If yousufforfrem bronchial asthma, you can also sufferfrom bronchospasms. If thisoccurs, immadiatelystopthatreatmarrt and consult a doctor.
- If you have a history of stomach ulcers, because AceCil 600mg Effervescent Tablets can irritate your stomach wall. Especially if you use other medicines known to irritate the stomach wall.
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* Rare cases of severe allergic reactions with (high) fever, red spotted skin, aching joints and/or eye inflammations (Stevens-Johnson syndrome) or accute hypersensitivity reactions with fever and blistery skin or shedding of skin (lye II syndrome) which were linked to the use of AceCil GOOmg Effervescent Tablets have been reported. In most cases at least one other medicine most likely causing the reaction was taken. If you notice new changes to your skin or mucus, immediately stop taking acetylcysteine and seek medical advise.
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* Especially at the start of treatment, the sticky mucus can increase in volume due to the fact that it will liquify. If you are unable to cough up this liquid mucus effectively, immediately consult your
doctor so that appropriate moasura can ba taken to remove mucus.
Children and adolescents
Mucolytics, such as AceCil GOOmg Effervescent Tablets, can block the airway of children under the ap of 2 years, due to the properties of the airway in this ap catepry. The abiltiy to cough up mucus may he limited. Therefore, this medicine is not suitable for children under 2 years of ap.
AceCil 600mg Effervescent Tablets should not be used in children between 2 and 18 years of ap.
Other medicines and AceCil GOOmg Effervescent Tablets
Tell pur doctor or pharmacist if you are taking, have recently taken or mipt take any other medicines.
If pu are taking other medicines, do not dissolve them simultaneously with this medicine.
If pu use antibiotics, it is advised to take these two hours before or after taking acetylcysteine.
Concomittant use of acetylcysteine and cough reflex muffling medicines is not allowed, because it is necessary to cough up the loosed mucus.
This medicine can strengthen the blood pressure lowering effect of nitroglycerin (medicine used apinst an o ppressive painful sensation in the chest (angina pectoris)). Caution is advised.
Whenusingactivatedcarton (aremedyfortraraler'sdiarriiea),theeffectof AceCil 600mgEffervescentTablets maydecline.
Prepancy and breast-feeding
If pu are prepant or breast-feeding, thinkpu may be prepant or are planningto have a baby, askpur doctor or pharmacist for advice before taking this medicine.
Prepancv
Oue to the aspartame content prepant women sufferingfrem phenylketonuria should not use AceCil GOOmg Effervescent Tablets.
Data about acetyl cystein s use in prepant woman is limited. Animal testing have shown no or indirect harmful effects on prepancy or the development of the child before, during and after birth. Ose AcaCil GOOmg Effervescent Tablets only after careful consideration of the advantages and disadvantages duringprepancy.
Breastfeeding
It is unknown if acetylcysteine passes into breast milk. Oso AceCil GOOmg Effervescent Tablets only after careful consideration of the advantaps and disadvantagas during prepancy.
Driving and using machines
There are no data on the effect of acetylcysteine on the ability to drive. However, an effect is unlikely.
AceCil 600mg Effervescent Tablets contains sodium and aspartame
This medicine contains 14G mg sodium (main component of cooking/table salt) in each effervescent tablet. This is equivalent to 7.3% of the recommended maximum daily dietary intake of sodium for an adult. Caution is advised in patients with a contrelled sodium diet.
This medicine contains 20 mg aspartame in each effervescent tablet. Aspartame is a puree of phenylalanine. It may be harmful if you have phenyl keto n uria (PKA), a rare poetic disorder in which phenylalanine build up because the body cannot remora it properly.
3. how to take acecil goomg effervescent tablets
AceCil 600mg Effervescent Tablets
Acetylcysteine
Dissolve the offb rvesca rit tablet in half a glass of water. Drink th n snlutinn immediately.
Dn net use fur mure than 14 days withe nt co nsulti ng a doctor.
Ilse in children and adolescents
AceCil BOOmg Effervescent Tablets should nut be used in children under the age of 2 years.
AceCil BOOmg Effervescent Tablets is net suitable for children and adolascarrts up to 18 years. Other acetylcysteine containingfnrms and strengthsare more suitable forties patient group.
If ynu take more AceCil 60Bmg Effervescent Tablets than ynu should
Effects that may occur are nausea, vo m Ring a nd diarriiea.
Immediately contact your doctor if you take more AceCil 600mg Effervescent Tablets than you should.
If you forget to take AceCil BBBmg Effervescent Tablets
If you forget to take a dose and it is aImost time for your next dose, du not take the „forgotten“ dose, but continue with the schedule as shown under „Huw to take AceCil 6D0mg Effervescent Tablets“. Do not take a double dose to make upfor a forgotten dose.
If you have any further questions on the use of this medicine, ask your ductor or pharmacist.
4. possible side effects
like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately stop taking AceCil 6D0mg Effervescent Tablets and contact your doctor or go to the emergency department of a nearby hospital if any of the following side effects uccurs:
- shuck (strong decrease of blond pressure, paleness, agitatio n, weak pulse, clammy skin, decreased consciousness) by a sudden vasodilation resulting from severe hypersensitivity tn certain substances (anaphylactic shock).
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■ sudden accumulation of fluid in the skin and mucous membranes (e.g. throat or tonpe), breathing difficulties and/or itching and rash, often as an allergic reaction (angio edema).
Above reactions are very serious side effects. In the event that these reactio ns occur with you, it is possible that you have a serious allergic reaction tn this drag. Ton may need urgent medical atteotion nr need to be hospitalized.
This serious side effect is very rare (less than 1 in 10,ODD users) for. Alsu bleeding are vary rare.
Tell your doctor if you experience any of the following side effects:
- distress by cramping nf the muscles in the airways (bronchnspasm)
- difficult breathing, shortness of breath or difficulty breathing (dyspnea)
- Indigestion with symptoms like feeling of fullness in the upper abdumen, stomach pain, belching, nausea and heartburn (dyspepsia)
These side effects are rare (affects 1 to 10 users in 10,000).
> Hypersensitivity
This may manifest as bronchnspasm and dyspnea (see abnve), rapid heartbeat (tachycardia), itching (pruritus), rash with intense itching and hives (urticaria) and angioedema.
- Headache
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* Ringing in the oars (tinnitus)
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> Stomatitis (inflammation of the mouth)
- Diarrhea
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* Fever
- Lowered blood pressure
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■ Abdominal pain
- Nausea
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* Vnmiting
These side effects are uncommon (affects 1 to 10 users in 1,000).
If you have a history of gastric or duodenal ulcer, acetylcysteine may have an adverse effect on your stomach muccsa.
If ynu get any of the side effects? Or do you have any side effects not listed in this leaflet? Please cuntact your doctor or pharmacist.
In case ynu find that the drag is too strong nr ton weak, talk to your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talkto your doctor or pharmacist. This includes any pnssible side effects nut listed in this leaflet. Yuu can alsn report side effects directly via,
The Yellow Card Schema
Medicinesand Healthcare Products Regulatory Apncy
151 Buckinpam Palace Road
Victoria, London, SWIW9SZ, United Kingdom
Website: search for MHRA Yellow Card in the Googl a Play o r Apple App Stern
By reportingside effects you can help provide more information un the safety of this medicine.
5. how to store acecil 600mg effervescent tablets
Keep this medicine nut of the sight and reach of children.
Store in the original packap to protect from moisture and light. Keep the tablet containerwell closed.
Do net use this medicine after the expiry date which is stated an the label and cartnn after EXP. The expiry date refers to the last day of that month.
After first opening of the tube the medicine may be used for a maximum of 8 weeks.
Do net throw away any medicines via wastewater or household waste. Ask your pharmacist howto throw away medicines you no lonpr use. These measures will help protect the environment.
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6. Cuntents of the pack and other information
What AceCil BDOmg Effervescent Tablets contains
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- The active substance is acetylcysteine. Each effervescent tablet contains BDO mg acetylcysteine.
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- The other ingredients are citric acid (E33D), sodium hydrepn carbonate (E5DDII) (nquivalnnt to 148 mg sodium), aspartame (E951) (equiva Ie nt tn 11 mg phenylalanine), Puvido no K-30