Zyx mint – Hydrochloride

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3 mg lozenge benzydamine
hydrochloride

What Zyx mint is and what it is used for

Zyx mint contains the active substance benzydamine which belongs to the group of non-steroidal anti-inflammatory drugs ( NSAIDs ) and is used for local treatment in the oral cavity.

Zyx mint is used to relieve pain and irritation in the mouth and throat in adults and children over 6 years of age.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

Benzydamine hydrochloride found in Zyx mint may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Zyx mint

Do not take Zyx mint

  • if you are allergic to benzydamine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Zyx mint:

  • if you suffer from phenylketonuria, as Zyx mint contains a source of phenylalanine (the sweetener aspartame).
  • if you have or have had asthma because Zyx mint can cause spasms in the airways.
  • if you are allergic to acetylsalicylic acid or other anti-inflammatory and pain-relieving drugs called NSAIDs (eg diclofenac and ibuprofen ).
  • if you have an intolerance to some sugars, you should consult a doctor before taking this medicine.
  • In rare cases, ulceration in the mouth/throat may be a sign of a serious illness. If the pain in the throat or pharynx worsens or does not improve within 3 days of using the lozenges, or if you develop a fever or other symptoms, you should therefore see a doctor or dentist.

Other medicines and Zyx mint

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

Zyx mint with food and drink

Food and drink have no effect.

Pregnancy and breastfeeding

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

Zyx mint lozenges should not be used during pregnancy and breastfeeding.

Driving ability and use of machinery

Zyx mint does not affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.

Zyx mint contains excipients

  • Isomalt: If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
  • Aspartame : This medicine contains 3.5 mg of aspartame per lozenge corresponding to 3.5 mg/3202 mg. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in the body.
  • Mint flavor contains benzyl alcohol, citronellol, d-limonene, eugenol, geraniol, and linalool, and lemon flavor contains benzyl alcohol, citral, citronellol, d-limonene, geraniol, and linalool. These substances can cause allergic reactions.
  • Butylhydroxyanisole (E 320), which is an ingredient in the lemon flavor: Can cause local skin reactions (e.g. contact dermatitis) or be irritating to eyes and mucous membranes.

How to take Zyx mint

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

Recommended dose:

Adults and children over 6 years: 1 lozenge 3 times daily. Do not take more than 3 lozenges per day.

Use for children

Children aged 6-11 years: When children under twelve take Zyx mint lozenges, an adult should check that they are taken correctly.

Lozenges should not be given to children under six years of age.

Zyx mint should not be used for more than 7 days. If the symptoms have not improved after 3 days of treatment, a doctor or dentist should be contacted.

For use in the mouth and throat. Allow a lozenge to dissolve slowly in the mouth.

The lozenges should not be swallowed whole or chewed.

If you have taken too much Zyx mint

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.

There are very rare reports of children becoming agitated/anxious or affected by convulsions, sweating, involuntary muscle movements, tremors, and vomiting after taking benzydamine doses approximately 100 times higher than the strength of the lozenges.

If you have any further questions about this medicine, ask your doctor or pharmacist.

Possible side effects

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

Stop taking Zyx mint and contact your doctor immediately if you experience any of the following symptoms ( angioedema ):

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

Uncommon (may affect up to 1 in 100 users):

  • Photosensitivity (rash or sun damage).

Rare (may affect up to 1 in 1,000 users):

  • Burning sensation in the mouth or dry mouth (if this happens, drink some water to relieve the effect)

Very rare (may affect up to 1 in 10,000 users):

  • Sudden swelling of e.g. mouth and throat mucous membranes ( angioedema ).
  • Cramp in the larynx ( laryngospasm ).

Has been reported (occurring in an unknown number of users) :

  • The sensation of numbness in the mouth ( oral hypoaesthesia ).
  • Allergic reaction (hypersensitivity).
  • Severe allergic reaction (anaphylactic shock ), with signs such as difficulty breathing, chest pain or tightness and/or dizziness/fainting, severe itching or raised skin rash, swelling of the face, lips, tongue, and/or throat. This can be life-threatening.

How to store Zyx mint

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

Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.

Store in the original packaging. Moisture sensitive.

Store at a maximum of 25ºC.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

  • The active substance is benzydamine.
  • One lozenge contains 3 mg of benzydamine hydrochloride corresponding to 2.68 mg of benzydamine.
  • Other ingredients are isomalt (E 953), aspartame (E 951), levomenthol, citric acid monohydrate, lemon flavor, mint flavor, quinoline yellow (E 104), and indigo carmine (E 132).

Appearance and package sizes of the medicine

Zyx mint lozenges are green, and square with a depression in the middle.

Each package contains 20 or 30 lozenges.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Viatris AB

Box 23033

104 35 Stockholm

Manufacturer:

ACRAF S.p.A

Via Vecchia del Pinocchio, 22

60131 Ancona, Italy

PIERRE FABRE MEDICINE PRODUCTION

Site Dietétique et Pharmacie

Zone Industrielle de la Coudette

32290 Aignan, France

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