320 micrograms/ml oral solution
glycopyrronium
What Sialanar is and what it is used for
Sialanar contains the active substance glycopyrronium.
Glycopyrronium belongs to a group of medicines called quaternary ammonium anticholinergics, which are substances that block or reduce the signal transmission between nerve cells. This reduced signal transmission can deactivate the cells that produce saliva.
Sialanar is used to treat the overproduction of saliva in children and adolescents from 3 years of age.
Drooling or overproduction of saliva is a common symptom of many diseases of the nerves and muscles. It is mainly caused by impaired control of the muscles of the face. Acute increased drooling may be associated with inflammation, dental infections, or infection in your mouth.
Sialanar acts on the salivary glands to reduce saliva production.
What you need to know before using Sialanar
Do not give Sialanar about your child/teenager
- is allergic to glycopyrronium or any of the other ingredients of this medicine (listed in section 6)
- is pregnant or breastfeeding
- have glaucoma (increased pressure in the eye)
- unable to empty the bladder ( urinary retention )
- have severe kidney disease have a narrowing of the stomach (pyloric stenosis) or the intestines that cause vomiting
- have diarrhea (frequent, loose, and watery stools)
- have ulcerative colitis ( inflammation of the intestine)
- has pain and swelling in the abdomen (paralytic ileus )
- has myasthenia gravis (muscle weakness and fatigue)
- take any of the following medicines (see section Other medicines and Sialanar): solid medicine (eg tablets or capsules) of potassium chloride to be swallowed, anticholinergic medicines.
Warnings and cautions
Talk to your doctor or pharmacist before giving Sialanar, if your child has:
- heart disease, heart failure, irregular heartbeat, or high blood pressure
- digestive disorders (constipation; chronic heartburn and indigestion)
- high body temperature (fever)
- inability to sweat normally
- kidney problems or difficulty urinating
- the affected blood-brain barrier (the layer of cells that surround the brain)
If you are not sure if any of the above applies to your child, talk to a doctor or pharmacist before giving Sialanar.
Discontinue treatment and consult a prescribing physician in the following cases:
- pneumonia
- allergic reaction
- difficult to empty the bladder ( urinary retention )
- behavioral changes
- constipation
- fever
Avoid exposing the child to heat or very high temperatures (hot weather, high room temperature). This is to avoid overheating and the risk of heat stroke. Talk to your child’s doctor in hot weather to see if dose one of Sialanar should be lowered.
Reduced salivation can increase the risk of dental disease. The child’s teeth should therefore be brushed every day and the child should undergo regular dental check-ups.
Children with kidney problems may receive a lower dose.
Check the baby’s heart rate if it does not seem to be feeling well. Report a very slow or very fast heart rate to your doctor.
Long-term use
Efficacy and safety of long-term use of Sialanar have not been studied for use longer than 24 weeks. Continued use of Sialanar should be discussed with the child’s doctor every 3 months, to check that Sialanar is still right for the child.
Children under 3 years
This medicine is a form of medicine that should be swallowed with a dose that should only be used in children and adolescents from 3 years of age.
Sialanar is not recommended for children under 3 years of age.
Other medicines and Sialanar
Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
If Sialanar is taken with the following medicines, it may affect the way Sialanar or the medicines listed work or it may increase the risk of side effects:
- Potassium chloride solid form of medicine (eg tablets or capsules) to be swallowed (see section “Do not give Sialanar to your child or teenager”)
- anticholinergic drugs (see section “Do not give Sialanar to your child or teenager”)
- antispasmodics used to treat nausea or vomiting e.g. domperidone and metoclopramide
- topiramate used to treat epilepsy
- antihistamines, which are used to treat certain allergies
- neuroleptics/antipsychotics (clozapine, haloperidol, phenothiazines), used to treat certain mental illnesses
- skeletal muscle relaxant (botulinum toxin)
- antidepressants ( tricyclic antidepressants )
- opioids are used to treat severe pain
- corticosteroids, which are used to treat inflammatory diseases
Talk to your doctor or pharmacist for more information on medicines to avoid while taking Sialanar.
Pregnancy, breastfeeding, and fertility
This medicine is intended for use in children and adolescents. Sialanar should not be given if the patient is pregnant (or may be pregnant), or breastfeeding (see section 2 “Do not give Sialanar for the baby or teenager”). Discuss with your child’s doctor if there is a need for contraception.
Driving and using machines
Sialanar can affect vision and coordination skills. This can affect the ability of skills such as driving, cycling, or using machines. After receiving Sialanar, the patient should not drive, cycle or use machines until the effect on his vision and coordination has completely subsided. If you have any further questions, ask your doctor.
Sialanar contains sodium and benzoate (E211)
This medicine contains less than 1 mmol sodium (23 mg) per maximum dose, ie it is essentially ‘sodium-free’. This medicine contains 2.3 mg benzoate (E211) per ml.
How to use Sialanar
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Children and adolescents from 3 years to younger than 18 years:
Your doctor will decide on the right dose of Sialanar. The first dose will be calculated based on the weight of the baby. Dose increases are decided by the child’s doctor, using the table below as a guideline. Dose increases will depend on both the effect of Sialanar and any adverse reactions experienced by the patient (therefore several dose levels are shown in the table below). Section 4 covers possible side effects associated with the use of Sialanar. These should be discussed with your child’s physician at all contact with a physician, including when discussing an increase and decrease in dose, and at other times if you are concerned.
The child should be monitored regularly (at least every 3 months) to check that Sialanar is still the correct treatment for the child.
| Weight | Dose level 1 | Dose level 2 | Dose level 3 | Dose level 4 | Dose level 5 |
|---|---|---|---|---|---|
| kg | ml | ml | ml | ml | ml |
| 13-17 | 0.6 | 1.2 | 1.8 | 2.4 | 3.0 |
| 18-22 | 0.8 | 1.6 | 2.4 | 3.2 | 4.0 |
| 23-27 | 1.0 | 2.0 | 3.0 | 4.0 | 5.0 |
| 28-32 | 1.2 | 2.4 | 3.6 | 4.8 | 6.0 |
| 33-37 | 1.4 | 2.8 | 4.2 | 5.6 | 6.0 |
| 38-42 | 1.6 | 3.2 | 4.8 | 6.0 | 6.0 |
| 43-47 | 1.8 | 3.6 | 5.4 | 6.0 | 6.0 |
| ≥48 | 2.0 | 4.0 | 6.0 | 6.0 | 6.0 |
Give a dose that the doctor has prescribed to the child three times a day. Dose one should be given 1 hour before meals or 2 hours after meals.
One dose must be given at the same time each time about food intake. Do not give the medicine with high-fat foods.
How to take the medicine
Sialanar should be taken by mouth.
Use for children and adolescents
How to use the oral dosing syringe
Remove the child-resistant cap from the bottle.
Insert the syringe adapter with the hole into the neck of the bottle (this may have already been done by the pharmacy staff). Insert the end of the syringe into the syringe adapter and check that it is secure.
Hold the syringe in place and turn the bottle upside down. Carefully pull the plunger rod down to the correct level (see tables for correct dose ). Make sure you have the right level. The maximum volume of the highest dose one is
6 ml
Turn the bottle upside down.
Remove the syringe by holding the vial and gently twisting the oral syringe.
Place the syringe inside the baby’s mouth and push the plunger rod in slowly to gently release the medicine.
After use, leave the syringe adapter in the neck of the bottle. Replace the closure. The syringe should be washed gently with warm water and allowed to dry after each use (ie three times a day). Do not use a dishwasher.
If your child receives the medicine through a feeding tube, rinse the tube with 10 ml of water after giving the medicine.
If you have given too much Sialanar
It is important to ensure that the correct dose is given each time, to prevent the harmful effects of Sialanar due to dosing errors or overdose.
Before giving Sialanar, make sure you have pulled it up to the correct level on the syringe.
Contact a doctor immediately if the child is given too much Sialanar, even if the child seems to be feeling well.
If you forget to give Sialanar
Give the next dose when it’s time for it. Do not give a double dose to make up for a forgotten dose.
If you stop giving your child Sialanar
Sialanar is not expected to cause any discomfort when treatment is stopped. Your child’s doctor may decide to discontinue treatment with Sialanar if the side effect cannot be managed by lowering the dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, stop using the medicine and contact a doctor immediately:
- constipation (difficult to get the stool out) – very common
- difficult to urinate ( urinary retention ) – very common
- pneumonia (severe pneumonia ) – common
- allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness) – have been reported
The following side effects may be a sign of a severe allergic reaction. If they occur, stop taking Sialanar and contact a doctor or nearest emergency department immediately and take the medicine with you:
- swelling of the tongue, lips, face, or throat (possible signs of angioedema ) – have been reported
Other side effects are:
Very common (may affect more than 1 user in 10)
- dry mouth
- difficult to get the stool out (constipation)
- diarrhea
- vomiting
- flushing (transient reddening of the skin)
- nasal congestion
- inability to empty the bladder (urinary retention)
- decreased secretion production in the breast
- irritability
Common (may affect up to 1 in 10 people)
- upper respiratory tract infection ( infection of the chest)
- pneumonia (severe pneumonia)
- urinary tract infection
- drowsiness (sleepiness)
- oro ( agitation )
- fever ( pyrexia )
- nosebleeds ( epistaxis )
- rash
Uncommon (may affect up to 1 in 100 people)
- bad breath (halitosis)
- fungal infection (cod) in the throat (candida infection in the esophagus)
- abnormal contractions of the gastrointestinal tract when eating food (gastrointestinal motility disorders)
- a disorder of the intestinal muscles and nerves that causes obstruction or blockage (pseudoobstruction)
- dilation of the pupil of the eye ( mydriasis )
- involuntary eye movements ( nystagmus )
- headache
- dehydration
- thirsty in hot weather
Other side effects that occur with anticholinergics but the whose frequency with glycopyrronium is not known
- allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness)
- severe allergic reaction ( angioedema ); Symptoms include swelling, mainly of the tongue, lips, face, or throat
- restlessness; overactivity; shortened attention period; frustration; mood swings; tantrums or explosive behavior; excessive sensitivity; severity or depression; frequent crying attacks; fear
- insomnia (difficulty sleeping)
- elevated pressure in the eye (which can cause glaucoma ); photophobia (photosensitivity); dry eyes
- slow heart rate followed by fast heart rate, palpitations, and irregular heartbeat
- inflammation and swelling of the sinuses ( sinusitis )
- nausea
- dry skin
- impaired ability to sweat, which can cause fever and heat stroke
- the sudden need to urinate
Side effects can sometimes be difficult to recognize in patients with neurological problems who can not tell how they are feeling.
Reduce dose one to the one you used before and consult a doctor if you think that a troublesome side effect occurs after you have increased a dose.
Tell your doctor if you notice any behavioral or other changes in your child.
How to store Sialanar
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. This medicine must be used within 2 months of first opening the bottle.
Do not use this medicine after the expiry date which is stated on the label after “EXP”. The expiration date is the last day of the specified month.
Sialanar should not be used if the package has been opened or damaged.
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 to protect the environment.
Contents of the packaging and other information
Content declaration
The active substance is glycopyrronium.
Each ml of solution contains 400 micrograms of glycopyrronium bromide equivalent to 320 micrograms of glycopyrronium.
The other ingredients are sodium benzoate (E211) (see section 2 “Sialanar contains sodium and benzoate”), raspberry aroma (containing propylene glycol E1520), sucralose (E955), citric acid (E330), and purified water.
What the medicine looks like and the contents of the pack
Sialanar oral solution is a clear, colorless liquid. It is supplied in a 60 ml and 250 ml amber glass bottle in a cardboard box. Each carton contains a bottle, an 8 ml syringe for oral use, and a syringe adapter. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Provence Pharma Ltd
2 Dublin Landings
North Wall Quay
Dublin 1
Ireland
Manufacturer
Center for Pharmaceutical Specialties (CSP),
ZAC des Suzots,
35 rue de la Chapelle,
63450 Saint Amant Challenge,
France
Unither Liquid Manufacturing,
1-3 Allée de la Neste,
ZI de Sigal,
31770 Colomiers,
France