Declozit 200 mg/30 mg Film-Coated Tablets

DECLOZIT is a combination of two main ingredients: ibuprofen and pseudoephedrine hydrochloride. Ibuprofen belongs to a group of medicines called nonsteroidal anti- inflammatory medicines (known as NSAIDs), which reduce fever and relieve pain. The other active ingredient pseudoephedrine hydrochloride is a decongestant, which relieves nasal congestion.

DECLOZIT is used to relieve the symptoms of common cold, sinusitis (swelling of the sinuses), or flu. These symptoms include nasal congestion, headache, fever, body aches and pain.

Do not take DECLOZIT :

• If you are hypersensitive (allergic) to ibuprofen, pseudoephedrine, or similar medicines used to treat colds and flu, or any of the other ingredients of DECLOZIT (listed in section 6).
• If you had a severe allergic reaction to aspirin, such as asthma attacks, swelling, shock or hives in the past.
• If you have heart conditions or if you had a heart attack in the past (myocardial infarction).
• If you have high blood pressure (hypertension).
• If you have a condition which causes high blood sugar levels (diabetes mellitus).
• If you have an overactive thyroid ( hyperthyroidism).
• If you have a tendency to be easily and excessively excited (hyperexcitability).
• If you have an enlarged prostate (prostatic hypertrophy).
• If you have a tumour on your adrenal gland ( phaeochromocytoma ).
• If you have high pressure within your eye/s (glaucoma).
• If you have a history of fits (seizures).
• If you have an inflammatory disease caused when the immune system attacks its own tissues (systemic lupus erythematosus).
• If you have a history of stroke or risk factors for stroke.
• If you suffer from kidney or severe liver problems.
• If you have a history of stomach or intestinal bleeding, wounds in the stomach or intestines (ulceration) or tears in the stomach or intestines (perforation) related to using similar medicines in the past.
• If you have, or had in the past, ulcers, bleeding in the stomach or intestine (haemorrhage) or tears in the stomach or intestines (perforations).
• If you have bleeding problems or problems with blood clots.
• If you are pregnant do not use NSAIDs, including DECLOZIT at 30 weeks or later in your pregnancy unless specifically advised to do so by your healthcare professional because these medicines may cause problems in your unborn baby (see section titled Pregnancy, breastfeeding and fertility).
• If you are breastfeeding your baby.
• If you are taking monoamine oxidase inhibitor antidepressant treatment (medicine prescribed for depression, psychiatric or emotional conditions or Parkinson’s disease), or if you stopped this treatment less than 14 days ago (see Other medicines and DECLOZIT).
• If you are taking any other cold and flu medicines (see Other medicines and DECLOZIT).

DECLOZIT is not suitable for children under 12 years.

Do not share medicines prescribed for you with any other person. Always take DECLOZIT exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

The usual dose of DECLOZIT is:

Adults and children 12 years and older: Take one tablet every 4 to 6 hours. If symptoms do not respond to one tablet, a second tablet may be taken. Do not take more than 6 tablets in 24 hours.

DECLOZIT should be taken with a glass of water, with food or after meals. Do not take for cold for more than 7 days or for fever for more than 3 days, unless directed by a doctor. If the cold or fever persists or gets worse, or if new symptoms occur, consult a doctor.

Use the lowest effective dose for the shortest possible duration of treatment.

If you take more DECLOZIT than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take DECLOZIT

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of DECLOZIT , take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

DECLOZIT can have side effects. Not all side effects reported for DECLOZIT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DECLOZIT, please consult your healthcare provider for advice.

If any of the following happens, stop taking DECLOZIT and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS),
• sudden pus-filled blisters appearing on your skin, as this may be dues to a serious allergic reaction known as Acute generalised exanthematous pustulosis (AGEP).

These are all very serious side effects. If you have them, you may have had a serious reaction to DECLOZIT. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Worsening of infections such as necrotising fasciitis, a serious bacterial infection that destroys tissue under the skin, with symptoms such as blisters, fever, tiredness, and pain,
• worsening of infections such as aseptic meningitis, a swelling within the brain and spinal cord, with symptoms such as stiffness of the neck, headache, nausea, vomiting or fever,
• blood disorders which are usually detected in blood tests, but may be seen as pale skin, tiredness, fever, sore throat and mouth, small red spots on the skin, bruising or prolonged bleeding after injury. Blood disorders (such as agranulocytosis, leukopenia, haemolytic anaemia, ecchymoses) may be seen with symptoms of severe chills, mouth ulcers, headache, shortness of breath and dizziness (blood dyscrasias),
• fits (convulsions),
• damage to the nerve in the eye (toxic amblyopia), which shows symptoms such as a blind spot which becomes larger,
• damage to the nerve in the eye (ischaemic optic neuropathy), which shows symptoms such as pain in the eyes, loss of vision, flashing lights, double vision,
• stomach ulcers (peptic ulcers), tearing in the stomach or intestines (perforation), bleeding in the stomach or intestine (gastrointestinal bleeding), with symptoms such as blood in your stools or in your vomit, paleness, stomach pains or cramps, tiredness or black tarry stools,
• tightness of the chest, changes in the way your heart beats (dysrhythmias), for example, if you notice it beating faster (tachycardia),
• heart failure (cardiac arrest), heart attack (myocardial infarction), with symptoms such as severe chest pain, difficulty breathing, coughing, tiredness,
• chest pain (angina pectoris), or chest tightness with difficulty breathing (pulmonary oedema),
• swelling in the lungs (alveolitis), collection of white blood cells in the lungs (pulmonary eosinophilia), pulmonary oedema, with symptoms such as difficulty breathing, chest pain, coughing and tiredness,
• inflammation of the pancreas which causes severe pain in the abdomen and back (pancreatitis),
• abnormal tiredness, dark urine, stomach pain and yellowing of the eyes and skin (jaundice). These may be signs of inflammation in the liver (hepatitis/hepatic dysfunction),
• kidney failure (renal impairment or failure), lack of oxygen to the kidneys (renal papillary or tubular necrosis), with symptoms such as passing less urine, short breath, nausea, tiredness, swelling in your legs or ankles,
• shortness of breath or troubled breathing (dyspnoea),
• worsening of asthma or tightening of air passages which causes difficulty breathing, coughing, wheezing and chest tightness (bronchospasm),
• lack of blood flow to parts of your body causing a stroke (haemorrhagic stroke, ischaemic stroke).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• Dizziness,
• stomach cramps, pain or discomfort in the stomach area, pain in the upper stomach area (epigastric pain or discomfort), heartburn, nausea, dry mouth,
• vomiting, passing wind (flatulence), loose stools (diarrhoea), difficulty passing stools (constipation),
• skin rash,
• nervousness, restlessness, inability to fall asleep (insomnia).

Less frequent side effects:

• Disturbed sense of reality (psychotic reactions), feeling extremely sad (depression),
• headache, nervousness or irritability, confusion, seeing or hearing things that are not really there (hallucinations), agitation, tiredness,
• a disorder of the nerves which can cause weakness, tingling or numbness (peripheral neuropathy), feeling sleepy (drowsiness), trouble in sleeping,
• blurred or double vision or change in vision, swelling in the eye (conjunctivitis), dry, irritated or swollen eyes,
• ringing or buzzing in ears, lessened or changes in the way you hear,
• swelling due to fluid collecting in the body (oedema), high blood pressure (hypertension), unexplained nose bleeds, reddening of the face or neck (flushing),
• loss of appetite, upset stomach ( indigestion), swelling in the stomach (gastritis), blood in stools (melaena), vomiting blood (haematemesis), irritation, soreness of mouth, sores in the mouth (gingival ulceration or aphthous stomatitis, ulcerative stomatitis),
• swelling or inflammation of the small intestine (colitis and Crohn's disease, swelling of the food pipe (oesophagitis), narrowing of the intestine which shows symptom such as nausea or stomach pain (intestinal diaphragm-like stricture),
• hair loss (alopecia),
• unexplained vaginal bleeding, blood in urine, bladder infection (cystitis), passing a large amount of urine (polyuria),
• sense of whirling or dizziness (giddiness), sweating, muscle weakness, involuntary muscle movements (tremor),
• ringing in the ears (tinnitus),
• difficult or painful urination.

Side effects with an unknown frequency:

• Mood or mental changes,
• swelling or inflammation of the small intestine (enterocolitis),
• abnormal results in liver function tests,
• kidney stones (renal calculi or ureteral obstruction),
• changes in the way your body processes food (altered metabolism, changes in your blood sugar levels (disturbances of glucose metabolism),
• feeling worried (anxiety), abnormal behaviour, unrealistic feeling of well-being (euphoria),
• fear, feeling sleepy (somnolence),
• thirst,
• difficulty or pain when passing urine (micturition, dysuria).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “ 6.04 Adverse Drug Reaction Reporting Form ”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 and to Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088 By reporting side effects, you can help provide more information on the safety of DECLOZIT.

Store all medicines out of reach of children. Store at or below 25 °C, protected from light and air. Keep blister in carton until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).