PACKAGE LEAFLET: INFORMATION FOR THE USER

Wockhardt Cold Relief Capsules with Decongestant

Paracetamol, Caffeine and Phenylephrine hydrochloride

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Wockhardt Cold Relief Capsules with Decongestant carefully to get the best results from them.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please ask your pharmacist.

-    You must contact a doctor if your symptoms worsen or do not improve after 3 days.

-    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Wockhardt Cold Relief Capsules with Decongestant. In the rest of this leaflet it is called Cold Relief Capsules with Decongestant.

In this leaflet:

1.    What Cold Relief Capsules with Decongestant are and what they are used for

2.    Before you take Cold Relief Capsules with Decongestant

3.    How to take Cold Relief Capsules with Decongestant

4.    Possible side effects

5.    How to store Cold Relief Capsules with Decongestant

6.    Further information

1. What Cold Relief Capsules with Decongestant are and what they are used for

The name of your medicine is Cold Relief Capsules with Decongestant. These capsules contain a combination of paracetamol (a painkiller), caffeine (a mild stimulant) and phenylephrine (a decongestant).

Cold Relief Capsules with Decongestant are used to relieve the symptoms of the common cold, flu, nasal congestion, blocked nose and sinuses.

2. Before you take Cold Relief Capsules with Decongestant

You should not take Cold Relief Capsules with Decongestant if you:

•    are allergic (hypersensitive) to paracetamol, caffeine, phenylephrine or any of the other ingredients in Cold Relief Capsules with Decongestant (see section 6, Further information)

•    have had ulcers of the stomach or small intestine (peptic ulcer disease)

•    have an overactive thyroid

•    have swelling of blood vessels (aneurysms)

•    have very high blood pressure

•    have narrowing of blood vessels

•    suffer from a tumour called a phaeochromocytoma

•    suffer from an enlarged prostate

•    are taking antidepressants called monoamine oxidase inhibitors (MAOIs) such as moclobemide.

Talk to your doctor or pharmacist before taking Cold Relief Capsules with Decongestant if you:

•    are elderly

•    suffer from kidney disease

•    suffer from liver disease, particularly if caused by alcohol

•    suffer from alcoholism

•    suffer from asthma, particularly if your asthma is worsened by aspirin

•    suffer from heart disease such as high blood pressure, prinzmetal angina (chest pain) or thromboembolic disorders following myocardial infarction (reduced blood supply in veins or arteries following a heart attack) or a history of ischemic heart disease.

Caution should be exercised when taking paracetamol products prior to (less than 72 hours before) or at the same time as intravenous busulfan.

This medicine contains paracetamol; do not take with any other paracetamol-containing products at the same time.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by treatment with Cold Relief Capsules with Decongestant:

•    general anaesthetics such as halothane and cyclopropane

•    medicines used to treat bacterial infections (e.g. quinolone antibiotics such as enoxacin, pipemidic acid and ciprofloxacin and isoniazid used to treat tuberculosis)

•    medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital, phenytoin, primodone)

•    medicines used to treat depression (e.g. fluvoxamine, tricyclic antidepressants such as imipramine and monoamine oxidase inhibitors (MAOIs) such as moclobemide)

•    metoclopramide and domperidone (used to treat sickness and nausea)

•    oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT

•    warfarin and other coumarin medicines (used to thin the blood)

•    probenecid (used to treat gout)

•    diflunisal (an anti-inflammatory painkiller)

•    colestyramine (used to treat high cholesterol and in diseases of the intestine and liver)

•    benzodiazepine medicines (sedatives e.g. diazepam)

•    disulfaram (used to treat alcoholism)

•    lithium (used to treat manic depression/bipolar disorder)

•    mexilitine (used to treat abnormal heart rhythms)

•    phenylpropanolamine (a decongestant)

•    fluconazole or terbinafine (used to treat fungal infections)

•    clozapine (an antipsychotic used to treat schizophrenia)

•    diuretics such as hydrochlorothiazide

•    ephedrine, a stimulant used in dietary supplements such as Ma Huang

•    theophylline (used in the treatment of asthma)

•    alpha-blockers (used in high blood pressure and problems associated with enlarged prostate)

•    atropine (used in anaesthesia or to increases the heart rate)

•    ergot alkaloids (used in the treatment of migraines)

•    oxytocin (used to induce childbirth)

•    sympathomimetics (used to maintain blood pressure in critically ill patients)

•    intravenous busulfan (used in chemotherapy to treat cancer).

Pregnancy and breast-feeding

If you are pregnant or are breast-feeding you should only take this medicine if your doctor has specifically recommended it.

Driving and using machinery

It is possible that Cold Relief Capsules with Decongestant may cause dizziness. Do not drive or operate machinery if affected.

3. How to take Cold Relief Capsules with Decongestant

Always follow the instructions on the label. If you are not sure then ask your doctor or pharmacist for advice. Swallow capsules whole with a glass of water.

Adults and children over 12 years

•    1 to 2 capsules every 4 hours as required

•    do not take more than 8 capsules in 24 hours

•    do not exceed the recommended dose

•    if symptoms persist see your doctor

•    do not take for more than 3 days unless you have been told to do so by your doctor.

Children under 12 years

•    do not give to children under 12 years unless your doctor tells you to.

If you take more Cold Relief Capsules with Decongestant than you should

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to take Cold Relief Capsules with Decongestant

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed

4. Possible side effects

Like all medicines, Cold Relief Capsules with Decongestant can cause side effects, although not everybody gets them.

As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, stop taking this medicine immediately, and see your doctor or pharmacist:

• allergic reactions which may be severe such as skin rash, peeling of the skin, itching, swollen red areas of the skin, sometimes with shortness of breath or swelling of the mouth, lips, tongue, throat or face.

The use of this medicine over a long time can cause kidney problems. If you experience any side effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.

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: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cold Relief Capsules with Decongestant

Keep out of the sight and reach of children.

•    Cold Relief Capsules with Decongestant should be stored in a dry place below 25°C.

•    Store in the original container to protect from light; do not transfer to another container.

•    Cold Relief Capsules with Decongestant should not be taken after the expiry date on the label; the expiry date refers to the last day of the month.

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

6. Further information

What Cold Relief Capsules with Decongestant contain

The active ingredients are: paracetamol 300mg, caffeine 25mg and phenylephrine 5mg.

The other ingredients are: starch, colloidal anhydrous silica, magnesium stearate, gelatin and colours; quinoline yellow (E104), patent blue V (E131), titanium dioxide (E171) and black iron oxide (E172).

What Cold Relief Capsules with Decongestant look like and the contents of the pack

Cold Relief Capsules with Decongestant are hard, green and yellow, gelatine capsules. The medicine is supplied in a blister pack and outer cardboard carton.

Cold Relief Capsules with Decongestant are available on general sale in pack sizes of 8, 10, 12 and 16 capsules. Or in larger pack sizes (20, 24, 28, 30 and 32 capsules) from the pharmacy.

Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only).

Please be ready to give the following information:

Product name	Reference number
Cold Relief Capsules with Decongestant	29831/0173

This is a service provided by the Royal National Institute of Blind People. Leaflet Prepared: February 2015

PACKAGE LEAFLET: INFORMATION FOR THE USER Wockhardt Sinus Dual Relief Capsules

Paracetamol, Caffeine and Phenylephrine hydrochloride

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Wockhardt Sinus Dual Relief Capsules carefully to get the best results from them.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please ask your pharmacist.

-    You must contact a doctor if your symptoms worsen or do not improve after 3 days.

-    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Wockhardt Sinus Dual Relief Capsules. In the rest of this leaflet it is called Sinus Dual Relief Capsules.

In this leaflet:

1.    What Sinus Dual Relief Capsules are and what they are used for

2.    Before you take Sinus Dual Relief Capsules

3.    How to take Sinus Dual Relief Capsules

4.    Possible side effects

5.    How to store Sinus Dual Relief Capsules

6.    Further information

1. What Sinus Dual Relief Capsules are and what they are used for

The name of your medicine is Sinus Dual Relief Capsules. These capsules contain a combination of paracetamol (a painkiller), caffeine (a mild stimulant) and phenylephrine hydrochloride (a decongestant).

Sinus Dual Relief Capsules are used to relieve the symptoms of the common cold, flu, nasal congestion (blocked nose and sinuses).

2. Before you take Sinus Dual Relief Capsules

You should not take Sinus Dual Relief

Capsules if you:

•    are allergic (hypersensitive) to paracetamol, caffeine, phenylephrine hydrochloride or any of the other ingredients in Sinus Dual Relief Capsules (see section 6, Further information)

•    have had ulcers of the stomach or small intestine (peptic ulcer disease)

•    have an overactive thyroid

•    have swelling of blood vessels (aneurysms)

•    have very high blood pressure

•    have narrowing of blood vessels

•    suffer from a tumour called a phaeochromocytoma

•    suffer from an enlarged prostate

•    are taking antidepressants called monoamine oxidase inhibitors (MAOIs) such as moclobemide.

Talk to your doctor or pharmacist

before taking Sinus Dual Relief

Capsules if you:

•    are elderly

•    suffer from severe kidney disease

•    suffer from severe liver disease, particularly if caused by alcohol

•    suffer from alcoholism

•    suffer from asthma, particularly if your asthma is worsened by aspirin

•    suffer from heart disease,

high blood pressure such as prinzmetal angina (chest    ™

pain) or thromboembolic

disorders following myocardial infarction(reduced blood supply in veins or arteries following a heart attack) or a history of ischemic heart disease.

Caution should be exercised when taking paracetamol products prior to (less than 72 hours before) or at the same time as intravenous busulfan.

This medicine contains paracetamol; do not take with any other paracetamol-containing products at the same time.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by treatment with Sinus Dual Relief Capsules:

•    general anaesthetics such as halothane and cyclopropane

•    medicines used to treat bacterial infections (e.g. quinolone antibiotics such as enoxacin, pipemidic acid and ciprofloxacin and isoniazid used to treat tuberculosis)

•    medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital, phenytoin, primodone)

•    medicines used to treat depression (e.g. fluvoxamine, tricyclic antidepressants such as imipramine and monoamine oxidase inhibitors (MAOIs) such as moclobemide)

•    metoclopramide and domperidone (used to treat sickness and nausea)

•    oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT

•    warfarin and other coumarin medicines (used to thin the blood) as there is an increased risk of bleeding

•    probenecid (used to treat gout)

•    diflunisal (an anti-inflammatory painkiller)

•    colestyramine (used to treat high cholesterol and in diseases of the intestine and liver)

•    benzodiazepine medicines (sedatives e.g. diazepam)

•    fluconazole or terbinafine (used to treat fungal infections)

•    clozapine (an antipsychotic used to treat schizophrenia)

•    diuretics such as hydrochlorothiazide

•    ephedrine, a stimulant used in dietary supplements such as Ma Huang

•    disulfaram (used to treat alcoholism)

•    lithium (used to treat manic depression/bipolar disorder)

•    mexilitine (used to treat abnormal heart rhythms)

•    phenylpropanolamine (a decongestant)

•    theophylline (used in the treatment of asthma)

•    alpha-blockers (used in high blood pressure and problems associated with enlarged prostate)

•    atropine (used in anaesthesia or to increase the heart rate)

•    ergot alkaloids (used in the treatment of migraines)

•    oxytocin (used to induce childbirth)

•    sympathomimetics (used to maintain blood pressure in critically ill patients)

•    intravenous busulfan (used in chemotherapy to treat cancer).

Pregnancy and breast-feeding

If you are pregnant or are breast-feeding you should only take this medicine if your doctor has specifically recommended it.

Driving and using machinery

It is possible that Sinus Dual Relief Capsules may cause dizziness. Do not drive or operate machinery if affected.

3. How to take Sinus Dual Relief Capsules

Always follow the instructions on the pack. If you are not sure then ask your doctor or pharmacist for advice. Swallow capsules whole with a glass of water.

Adults and children over 12 years

•    1 to 2 capsules every 4 hours as required

•    do not take more than 8 capsules in 24 hours

•    do not exceed the recommended dose

•    if symptoms persist see your doctor

•    do not take for more than 3 days unless you have been told to do so by your doctor.

Children under 12 years

•    do not give to children under 12 years unless your doctor tells you to.

If you take more Sinus Dual Relief Capsules than you should

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to take Sinus Dual Relief Capsules

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

4. Possible side effects

Like all medicines, Sinus Dual Relief Capsules can cause side effects, although not everybody gets them.

As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, stop taking this medicine immediately, and see your doctor or pharmacist:

• allergic reactions which may be severe such as skin rash, peeling of the skin, itching, swollen red areas of the skin, sometimes with shortness of breath or swelling of the mouth, lips, tongue, throat or face.

Side effects that have been reported with Sinus Dual Relief Capsules are:

rash	• worsening of asthma
tremor	• anxiety
sleep disturbance	• restlessness
excitement	• palpitations
high blood pressure	• muscle weakness
acidosis (increased	• piloerection
acid concentration	(bristling of hairs
in the blood)	on the skin)
narrowing of blood vessels	• irritability
feeling sick	• acid reflux
bowel irritation	• insomnia
increased frequency	• lumps (cysts)
to urinate	in the breasts
irregular heart beat	• vomiting
problems passing	• changes in blood
water very rare cases of	cells
serious skin reactions have been reported

The use of this medicine over a long time can cause kidney problems. If you experience any side effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.

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: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sinus Dual Relief Capsules

Keep out of the sight and reach of children.

•    Sinus Dual Relief Capsules should be stored in a dry place below 25°C.

•    Store in the original container to protect from light; do not transfer to another container.

•    Sinus Dual Relief Capsules should not be taken after the expiry date on the pack; the expiry date refers to the last day of the month.

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

6. Further information

What Sinus Dual Relief Capsules contain

The active ingredients are: paracetamol 300mg, caffeine 25mg and phenylephrine hydrochloride 5mg.

The other ingredients are: starch, colloidal anhydrous silica, magnesium stearate, gelatine, and colours; quinoline yellow (E104), patent blue V (E131), titanium dioxide (E171) and black Iron oxide (E172).

What Sinus Dual Relief Capsules look like and the contents of the pack

Sinus Dual Relief Capsules are hard, green and yellow, gelatine capsules. The medicine is supplied in a blister pack and outer cardboard carton.

Sinus Dual Relief Capsules are available on general sale in pack sizes of 8, 10, 12 and 16 capsules or in larger pack sizes (20, 24, 28, 30 and 32 capsules) from the pharmacy.

Marketing Authorisation Holder:

Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK.

Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

Please be ready to give the following information:

Product name	Reference number
Wockhardt Sinus Dual Relief Capsules	29831/0173

This is a service provided by the Royal National Institute of Blind People.

Leaflet Prepared: February 2015

f,WOCKHARDT    105611/2

Code: PB/Drugs/1802-OSP