Solphyllex Syrup

SOLPHYLLEX SYRUP belongs to a group of medicines used in the treatment of cough and cold ailments. SOLPHYLLEX SYRUP is indicated for the prompt relief of coughs associated with respiratory infection, asthma and allergy. SOLPHYLLEX SYRUP can be used for prolonged therapy as it is considered a non-addictive.

Do not take SOLPHYLLEX SYRUP if you suffer from:

• Hypersensitivity (you are allergic) to theophylline, etofylline, diphenylpyraline hydrochloride, ammonium chloride, sodium citrate or any of the other ingredients of SOLPHYLLEX SYRUP (listed in section 6)
• diabetes (high blood sugar)
• hypersensitivity to antihistamines (medications used to relieve allergy symptoms)
• kidney or liver disease
• severe hypotension (low blood pressure)
• peptic ulcers (a painful sore that develops on the lining of your stomach, small intestine, or oesophagus)
• gout (a condition that causes sudden and severe pain, redness, and swelling in your joints)
• alcoholism (including rehabilitated alcoholics).

Warnings and precautions

Special care should be taken:

• If you take more than the recommended dose as you may experience gastrointestinal (stomach) discomfort like nausea, vomiting and pain.
• if you are undergoing routine haemodialysis treatment (for certain kidney problems), as you may require increased doses of SOLPHYLLEX SYRUP (see section 3. ‘How to take SOLPHYLLEX SYRUP).

Other medicines and SOLPHYLLEX SYRUP

Always tell your health care provider if you are taking any other medicine (this includes all complementary or traditional medicines). The below medicines/medicine groups may interact with and alter the effectiveness of SOLPHYLLEX SYRUP:

• Taking xanthine or sympathomimetics (i.e. medicines that mimic the effects of adrenaline by stimulating the nervous system like caffeine and asthma medication) with theophylline can make theophylline work too strongly, which might lead to more intense effects and increase the risk of side effects. Theophylline, an ingredient in SOLPHYLLEX SYRUP, is used to help open up your airways, but combining it with these other drugs can make it more likely to cause problems.
• if you are a smoker, you should speak to your healthcare provider as you might need higher amounts of medication to get the same effect as non-smokers.
• diphenylpyraline hydrochloride, as contained in SOLPHYLLEX SYRUP can affect your body's natural chemicals and might not be safe for people with certain conditions like glaucoma (eye pressure issues) or prostate problems. It could also make the effects of medications like atropine (often used for various conditions) and tricyclic antidepressants (a type of mood medication) stronger.
• SOLPHYLLEX SYRUP, can make you feel even more sleepy or relaxed if you’re also taking other medicines that depress the central nervous system, like alcohol, strong painkillers, or sedatives.

SOLPHYLLEX SYRUP with alcohol

SOLPHYLLEX SYRUP contains 0,15 mL of alcohol (ethanol) in each 30 mL dose which is equivalent to 0,005 mL of alcohol (ethanol) per mL of syrup. SOLPHYLLEX SYRUP, can further impair your concentration and make you feel even more sleepy or relaxed if also taken with alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine.

Driving and using machinery

SOLPHYLLEX SYRUP may cause drowsiness and impaired concentration which may affect your ability to perform skilled tasks; if you are affected, you should not drive or operate machinery. It is not always possible to predict to what extent SOLPHYLLEX SYRUP may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which SOLPHYLLEX SYRUP affects you (see section 4).

SOLPHYLLEX SYRUP contains Sucrose (a form of sugar) If you suffer from diabetes mellitus. SOLPHYLLEX SYRUP contains 17,13 g of sucrose per 30 mL or 0,5 mg/mL of syrup. This should be taken into account if you suffer with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars. You should contact your doctor before taking this medicinal product. This medicine may also be harmful to the teeth.

Sodium (a component of table salt) This medicine contains 2,45 mg sodium (main component of cooking/table salt) in each mL of syrup. This is equivalent to 5,5 % of the recommended maximum daily dietary intake of sodium for an adult.

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

The usual dose is:

• Adults: Three medicine measures (15 mL) three times daily after meals and at bedtime.
• Children (2 - 12 years): Two medicine measures (10 mL) three times daily after meals and at bedtime.

You should not exceed the recommended dose (see Warnings and precautions). SOLPHYLLEX SYRUP is to be taken orally.

In patients with kidney problems

If you're on regular kidney dialysis, you might need higher doses of SOLPHYLLEX SYRUP. Speak to your doctor before taking this medicine.

If you take more SOLPHYLLEX SYRUP than you should

Taking more than the recommended dose of SOLPHYLLEX SYRUP, will cause stomach irritation due to theophylline, an ingredient of SOLPHYLLEX SYRUP. It may also lead to nausea, vomiting, thirst, headache, hyperventilation (rapid breathing), increasing drowsiness, low blood-potassium levels (which may present as weakness, muscle cramps, rapid beating of the heart), mental confusion and electrolyte imbalances in the blood which can lead to kidney failure, due to ammonium chloride, an ingredient of SOLPHYLLEX SYRUP. Feeling sleepy, dizziness, muscular weakness and poor coordination may also occur when too much SOLPHYLLEX SYRUP is taken. In infants and children, large doses may lead to seizures and fevers due to antihistamines, a constituent of SOLPHYLLEX SYRUP. Since there is no specific antidote for antihistamine (a component of SOLPHYLLEX SYRUP) poisoning, it is important to keep SOLPHYLLEX SYRUP out of the reach and sight of young children. In the event of overdosage, consult your doctor or pharmacist even if you do not notice the symptoms. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take SOLPHYLLEX SYRUP

Do not take a double dose to make up for forgotten individual doses.

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

If any of the following happens, stop taking SOLPHYLLEX SYRUP 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.

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

Tell your doctor if you notice any of the following:

Frequency unknown:

• Gastrointestinal disturbances (nausea, vomiting, pain in the stomach)

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 or pharmacist or nurse. You can also report side effects to SAHPRA via the ‘Med Safety App’ (Med Safety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA’s website. By reporting side effects, you can help provide more information on the safety of SOLPHYLLEX SYRUP. You may also report to Adcock Ingram Limited using the following email: [email protected].

Store all medicines out of reach and sight of children. Store at or below 25 °C. Keep the bottle tightly closed. Protect from light. Do not store in a bathroom. Do not use after the expiry date stated on the bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).